<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04505813</url>
  </required_header>
  <id_info>
    <org_study_id>NEXI-002-01</org_study_id>
    <nct_id>NCT04505813</nct_id>
  </id_info>
  <brief_title>Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma</brief_title>
  <official_title>A Phase 1 / 2 Study to Evaluate the Safety and Tolerability of Adoptively Transferred Autologous T Cells in Patients With Relapsed Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NexImmune Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NexImmune Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Research study is being done to characterize the safety, tolerability, and preliminary&#xD;
      antitumor activity of the NEXI-002 T cell product (a new experimental therapy), which&#xD;
      contains populations of CD8+ T cells targeting multiple Myeloma associated antigen peptides&#xD;
      in patients with relapsed refractory multiple myeloma (MM).&#xD;
&#xD;
      The study will enroll patients with MM who have relapsed or are refractory to standard lines&#xD;
      of treatment.&#xD;
&#xD;
      The enrolled patients will undergo bridging therapy for the purposes of disease control while&#xD;
      the NEXI-002 T cell product is being manufactured. Choice of bridging therapy administered&#xD;
      will be per the Investigator's discretion, but is limited to acceptable agents as specified&#xD;
      in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy,&#xD;
      with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD&#xD;
      therapy. Within 72 hours after completing LD therapy, patients will receive a single IV&#xD;
      infusion of the NEXI-002 T cell product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NEXI-002 is an adoptive cellular therapy product which contains populations of&#xD;
      antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-002 T cell&#xD;
      product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the patient.&#xD;
      During the manufacturing process, these cells are primed and expanded ex vivo using nano-size&#xD;
      artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen&#xD;
      peptides in combination with a proprietary T cell enrichment and expansion process.&#xD;
&#xD;
      The NEXI-002 T cell product is restricted to patients that are HLA-A2.01 allele positive for&#xD;
      this study.&#xD;
&#xD;
      There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The&#xD;
      Safety Evaluation Phase will determine the safety and tolerability of a single dose of&#xD;
      NEXI-002 T cell product, and will consist of Dose Escalation at two dose levels - each with&#xD;
      cohorts of three patients.&#xD;
&#xD;
      When all three patients at Dose Level 1 have dosed and cleared the DLT period, three&#xD;
      additional patients will be enrolled at Dose Level 2. When three patients have cleared the&#xD;
      DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase.&#xD;
      The Dose Expansion Phase will enroll up to 16 additional patients to further define the&#xD;
      safety and evaluate the initial anti-tumor efficacy of the NEXI- 002 T cell product at the&#xD;
      dose established from the Safety Evaluation Phase.&#xD;
&#xD;
      All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 002 T&#xD;
      cell product. During this phase, all patients will be monitored for AEs and followed for&#xD;
      anti-leukemia response until the end of study visit is complete (up to one year).&#xD;
&#xD;
      Additional assessments for safety, disease status, and other secondary and exploratory&#xD;
      endpoints will also be monitored during the follow-up period.&#xD;
&#xD;
      All patients will be followed for overall survival (OS) from time of disease progression&#xD;
      until the last visit of the last patient. During this time, patients will be followed via&#xD;
      telephone or other electronic contact at 12 week intervals for monitoring of OS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Lack of accrual&#xD;
  </why_stopped>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events of Special Interest (AESIs) events</measure>
    <time_frame>1 year</time_frame>
    <description>1) Dose Limiting Toxicities (DLTs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progressive Free Survival</measure>
    <time_frame>At 12 months</time_frame>
    <description>Median Progressive free Survival (PFS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Response Survival (Rate)</measure>
    <time_frame>At 12 months</time_frame>
    <description>Overall Response Rate (ORR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>At 12 months</time_frame>
    <description>Overall Survival (OS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events (AEs) Reporting</measure>
    <time_frame>At year 1</time_frame>
    <description>Incidence of TEAEs leading to study withdrawal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events of Special Interest (AESIs) events (AEs) Reporting</measure>
    <time_frame>at year 1</time_frame>
    <description>Cytokine Release Syndrome (CRS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events of Special Interest (AESIs)events (AEs) Reporting (ICANS)</measure>
    <time_frame>at year 1</time_frame>
    <description>Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events of Special Interest (AESIs)events (AEs) Reporting-TEAEs</measure>
    <time_frame>At year 1</time_frame>
    <description>For Incidence of TEAEs and serious TEAEs (Treatment-emergent adverse events (TEAEs) are defined as those AEs that started on or after LD therapy or that worsened after LD therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events of Special Interest (AESIs)events (AEs) Reporting-Infusion Reactions</measure>
    <time_frame>At year 1</time_frame>
    <description>Infusion Related Reactions (IRR)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Relapsed Refractory Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Safety Evaluation Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with NEXI-002 T cells, derived from PBMCs of the patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI- 002 T cell product at the dose established from the Safety Evaluation Phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NEXI-002 T Cells</intervention_name>
    <description>The NEXI-001 T cell product will be administered as a single IV infusion to patients within 72 hours after completing LD therapy.</description>
    <arm_group_label>Dose Expansion Phase</arm_group_label>
    <arm_group_label>Safety Evaluation Phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide informed consent and documentation of informed consent prior to&#xD;
             initiation of any study-related tests or procedures that are not part of&#xD;
             standard-of-care for the patient's disease. Patients must also be willing and able to&#xD;
             comply with study procedures, including the acquisition of specified research&#xD;
             specimens&#xD;
&#xD;
          2. Age ≥ 18 years old &amp; life expectancy &gt; 3 months&#xD;
&#xD;
          3. Expression of HLA-A*0201 as determined by high resolution sequence-based typing method&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with exception&#xD;
             of ECOG &gt; 1 if related to recent bone fracture&#xD;
&#xD;
          5. Patients must have confirmed diagnosis of MM&#xD;
&#xD;
          6. Have identified relapsed/refractory disease which includes:&#xD;
&#xD;
               1. Previous therapy consisting of at least three (3) standard regimens, including a&#xD;
                  proteasome inhibitor, IMiD, or anti-CD38 targeting therapy.&#xD;
&#xD;
                  Note: Induction therapy, autologous stem cell transplantation (ASCT) &amp;&#xD;
                  maintenance therapy if given sequentially without intervening progressive disease&#xD;
                  (PD) are considered one 'regimen'&#xD;
&#xD;
               2. Refractory MM may be defined as disease that is refractory to treatment while on&#xD;
                  therapy or that shows progression within 60 days of the last therapy.&#xD;
&#xD;
          7. Have measurable disease as defined by:&#xD;
&#xD;
               1. Serum M protein ≥ 0.5 g/dL&#xD;
&#xD;
               2. Urine M protein ≥ 200 mg/24hr&#xD;
&#xD;
               3. Serum free light chains (FLC) ≥ 10 mg/dL with abnormal FLC ratio Note: Patients&#xD;
                  with IgA MM in whom serum protein electrophoresis (sPEP) is deemed unreliable,&#xD;
                  due to co-migration of normal serum proteins with the paraprotein in the β&#xD;
                  region, may be considered eligible as long as total serum IgA level is &gt; normal&#xD;
                  range.&#xD;
&#xD;
          8. Acceptable laboratory parameters as follows:&#xD;
&#xD;
               1. AST/ALT ≤ 2.5 × ULN&#xD;
&#xD;
               2. Total bilirubin ≤ 1.5 × ULN, except patients with Gilbert's syndrome, who may&#xD;
                  enroll if the conjugated bilirubin is within normal limits&#xD;
&#xD;
               3. Serum creatinine ≤ 2.5 mg/dL or estimated creatinine clearance (CL) ≥ 30 mL/min &amp;&#xD;
                  not dialysis-dependent&#xD;
&#xD;
               4. ALC &gt; 1000 cells/µL&#xD;
&#xD;
          9. Recovery to Grade 1 or baseline of non-hematologic toxicities from prior treatments,&#xD;
             excluding alopecia &amp; Grade 2 peripheral neuropathy&#xD;
&#xD;
         10. Female patients of childbearing potential must test negative for pregnancy at&#xD;
             enrollment and during the study. Sexually active women of child-bearing potential,&#xD;
             unless surgically sterile, must be willing to use a highly effective method of birth&#xD;
             control defined as those which result in a low failure rate (i.e., less than 1% per&#xD;
             year) such as implants, injectables, combined oral contraceptives, intra-uterine&#xD;
             devices (IUDs) or vasectomized partner&#xD;
&#xD;
         11. Male patients with partners of childbearing potential must be either vasectomized or&#xD;
             agree to use a condom in addition to having their partners use another method of&#xD;
             contraception resulting in a highly effective method of birth control defined as those&#xD;
             which result in a low failure rate (i.e., less than 1% per year) such as implants,&#xD;
             injectables, combined oral contraceptives, or IUDs. Patients should not have sexual&#xD;
             intercourse with females who are either pregnant or lactating without double-barrier&#xD;
             contraception • Is not pregnant or breastfeeding, or expecting to conceive or father&#xD;
             children within the projected duration of the trial, starting with the prescreening or&#xD;
             screening visit through one year from administration of NEXI-002 T cells&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have active cerebral or meningeal disease related to the underlying malignancy&#xD;
&#xD;
          2. Have hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS&#xD;
             syndrome, amyloidosis, plasmacytoma, significant autoimmune or other malignant disease&#xD;
&#xD;
          3. History of allogeneic hematopoietic stem cell transplantation&#xD;
&#xD;
          4. Have active or uncontrolled infections with positive cultures and/or requiring&#xD;
             treatment with IV anti-infective agents&#xD;
&#xD;
          5. Echocardiogram or MUGA with left ventricular ejection fraction &lt; 45%&#xD;
&#xD;
          6. History of clinically significant cardiovascular disease including but not limited to:&#xD;
&#xD;
               1. Myocardial infarction or unstable angina within the 6 months prior to the&#xD;
                  initiation of study&#xD;
&#xD;
               2. Stroke or transient ischemic attack within 6 months prior to initiation of study&#xD;
&#xD;
               3. Clinically significant cardiac arrhythmia&#xD;
&#xD;
               4. Uncontrolled hypertension: systolic blood pressure (SBP) &gt; 180 mmHg, diastolic&#xD;
                  blood pressure (DBP) &gt; 100 mmHg&#xD;
&#xD;
               5. Congestive heart failure (New York Heart Association [NYHA] class III-IV)&#xD;
&#xD;
               6. Pericarditis or clinically significant pericardial effusion&#xD;
&#xD;
               7. Myocarditis&#xD;
&#xD;
          7. Clinically significant pulmonary compromise, including a requirement for supplemental&#xD;
             oxygen use to maintain adequate oxygenation&#xD;
&#xD;
          8. Eligible patients will not be on any steroids ≥10 mg per day prednisone or equivalent&#xD;
             or other immunosuppressants such as tacrolimus, cyclosporine, etc.&#xD;
&#xD;
             a. Intermittent topical, inhaled or intranasal corticosteroids are allowed&#xD;
&#xD;
          9. History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) requiring&#xD;
             systemic anticoagulation within 6 months before enrollment&#xD;
&#xD;
         10. History of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus&#xD;
             erythematosus, etc.) resulting in end organ injury or requiring systemic&#xD;
             immunosuppression / systemic disease modifying agents within the last 2 year prior to&#xD;
             enrollment. Subjects with a history of autoimmune-related hypothyroidism on a stable&#xD;
             dose of thyroid replacement hormone and subjects with controlled Type 1 diabetes&#xD;
             mellitus on a stable insulin regimen may be eligible for the study&#xD;
&#xD;
         11. Human immunodeficiency virus (HIV) seropositive; HIV testing within 2 years of&#xD;
             enrollment&#xD;
&#xD;
         12. Seropositive for and with evidence of active viral infection with hepatitis B virus&#xD;
             (HBV). Patients who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA&#xD;
             negative are eligible&#xD;
&#xD;
               1. Patients who had HBV but have received an antiviral treatment and show&#xD;
                  non-detectable viral DNA for 6 months are eligible&#xD;
&#xD;
               2. Patients who are seropositive because of HBV vaccine are eligible&#xD;
&#xD;
         13. Seropositive for and with active viral infection with hepatitis C virus (HCV)&#xD;
&#xD;
             a. Patients who had HCV but have received an antiviral treatment and show no&#xD;
             detectable HCV viral DNA for 6 months are eligible&#xD;
&#xD;
         14. Second primary invasive malignancy that has not been in remission for more than 2&#xD;
             years. Exceptions that do not require a 2-year remission include: non-melanoma skin&#xD;
             cancer; carcinoma in situ (cervix, bladder, breast, etc.) or squamous intraepithelial&#xD;
             lesion on Pap smear; localized prostate cancer (Gleason score &lt; 6); or resected&#xD;
             melanoma in situ&#xD;
&#xD;
         15. History of trauma or major surgery within 4 weeks prior to the initiation of study&#xD;
&#xD;
         16. Any serious underlying medical or psychiatric condition that would impair the ability&#xD;
             of the patient to receive or tolerate the planned treatment and follow up&#xD;
&#xD;
         17. Known hypersensitivity to any component of NEXI-002 T cells, cyclophosphamide,&#xD;
             fludarabine or tocilizumab&#xD;
&#xD;
         18. Vaccination with any live virus vaccine within 6 weeks prior to the initiation of&#xD;
             study treatment. Inactivated annual influenza vaccination is allowed&#xD;
&#xD;
         19. Dementia or altered mental status that would preclude understanding and rendering of&#xD;
             informed consent&#xD;
&#xD;
         20. History of seizures, aphasia, psychosis or other chronic clinically significant&#xD;
             neurologic disorders&#xD;
&#xD;
             a. Patients with remote history of seizures that are well controlled on anti-seizure&#xD;
             medications and without any seizure episode for 6 months are eligible&#xD;
&#xD;
         21. Any issue that in the opinion of the investigator, would contraindicate the patient's&#xD;
             participation in the study or confound the results of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Knight, MD</last_name>
    <role>Study Chair</role>
    <affiliation>NexImmune</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health Medical Group Blood &amp; Marrow Transplant</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04505813
org study id: NEXI-002-01
nct id: NCT04505813
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Research study is being done to characterize the safety, tolerability, and preliminary
      antitumor activity of the NEXI-002 T cell product (a new experimental therapy), which
      contains populations of CD8+ T cells targeting multiple Myeloma associated antigen peptides
      in patients with relapsed refractory multiple myeloma (MM).

      The study will enroll patients with MM who have relapsed or are refractory to standard lines
      of treatment.

      The enrolled patients will undergo bridging therapy for the purposes of disease control while
      the NEXI-002 T cell product is being manufactured. Choice of bridging therapy administered
      will be per the Investigator's discretion, but is limited to acceptable agents as specified
      in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy,
      with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD
      therapy. Within 72 hours after completing LD therapy, patients will receive a single IV
      infusion of the NEXI-002 T cell product.
The NEXI-002 is an adoptive cellular therapy product which contains populations of
      antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-002 T cell
      product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the patient.
      During the manufacturing process, these cells are primed and expanded ex vivo using nano-size
      artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen
      peptides in combination with a proprietary T cell enrichment and expansion process.

      The NEXI-002 T cell product is restricted to patients that are HLA-A2.01 allele positive for
      this study.

      There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The
      Safety Evaluation Phase will determine the safety and tolerability of a single dose of
      NEXI-002 T cell product, and will consist of Dose Escalation at two dose levels - each with
      cohorts of three patients.

      When all three patients at Dose Level 1 have dosed and cleared the DLT period, three
      additional patients will be enrolled at Dose Level 2. When three patients have cleared the
      DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase.
      The Dose Expansion Phase will enroll up to 16 additional patients to further define the
      safety and evaluate the initial anti-tumor efficacy of the NEXI- 002 T cell product at the
      dose established from the Safety Evaluation Phase.

      All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 002 T
      cell product. During this phase, all patients will be monitored for AEs and followed for
      anti-leukemia response until the end of study visit is complete (up to one year).

      Additional assessments for safety, disease status, and other secondary and exploratory
      endpoints will also be monitored during the follow-up period.

      All patients will be followed for overall survival (OS) from time of disease progression
      until the last visit of the last patient. During this time, patients will be followed via
      telephone or other electronic contact at 12 week intervals for monitoring of OS.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events of Special Interest (AESIs) events
time frame: 1 year
description: 1) Dose Limiting Toxicities (DLTs).
measure: Progressive Free Survival
time frame: At 12 months
description: Median Progressive free Survival (PFS)
measure: Overall Response Survival (Rate)
time frame: At 12 months
description: Overall Response Rate (ORR)
measure: Survival
time frame: At 12 months
description: Overall Survival (OS)
measure: Adverse events (AEs) Reporting
time frame: At year 1
description: Incidence of TEAEs leading to study withdrawal
measure: Adverse Events of Special Interest (AESIs) events (AEs) Reporting
time frame: at year 1
description: Cytokine Release Syndrome (CRS)
measure: Adverse Events of Special Interest (AESIs)events (AEs) Reporting (ICANS)
time frame: at year 1
description: Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)
measure: Adverse Events of Special Interest (AESIs)events (AEs) Reporting-TEAEs
time frame: At year 1
description: For Incidence of TEAEs and serious TEAEs (Treatment-emergent adverse events (TEAEs) are defined as those AEs that started on or after LD therapy or that worsened after LD therapy.
measure: Adverse Events of Special Interest (AESIs)events (AEs) Reporting-Infusion Reactions
time frame: At year 1
description: Infusion Related Reactions (IRR)
arm group label: Safety Evaluation Phase
arm group type: Experimental
description: Treatment with NEXI-002 T cells, derived from PBMCs of the patient
arm group label: Dose Expansion Phase
arm group type: Experimental
description: Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI- 002 T cell product at the dose established from the Safety Evaluation Phase.
intervention type: Biological
intervention name: NEXI-002 T Cells
description: The NEXI-001 T cell product will be administered as a single IV infusion to patients within 72 hours after completing LD therapy.
arm group label: Dose Expansion Phase
arm group label: Safety Evaluation Phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Knight, MD
role: Study Chair
affiliation: NexImmune
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No