xml: <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/NCT05967416</url>
    </required_header>
    <id_info>
      <org_study_id>SIRP01-1001</org_study_id>
      <nct_id>NCT05967416</nct_id>
    </id_info>
    <brief_title>Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma</brief_title>
    <official_title>Phase 1, Open-Label Study of Autologous SIRPα-low Macrophages (SIRPant-M) Administered by Intratumoral Injection Alone or in Combination With Focal External-Beam Radiotherapy in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SIRPant Immunotherapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>SIRPant Immunotherapeutics, 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>
        The goal of this study is to test SIRPant-M, an autologous cell therapy, alone or in&#xD;
        combination with focal external-beam radiotherapy in participants with relapsed or refractory&#xD;
        non-Hodgkin's lymphoma (NHL). Two dose levels of SIRPant-M are being tested. The main&#xD;
        question this study aims to answer is if SIRPant-M alone or in combination with radiotherapy&#xD;
        is safe and well-tolerated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label phase 1 study of SIRPant-M studied in serial cohorts either alone&#xD;
        (monotherapy), or combined with low-dose focal external-beam radiotherapy (XRT) in patients&#xD;
        with relapsed- or refractory Non-Hodgkin's lymphoma (NHL). Both B-cell and certain T-cell NHL&#xD;
        (select PTCL; CTCL) are eligible. The primary objective of the study is to assess the safety&#xD;
        and tolerability of autologous SIRPant-M, delivered by 3 intra-tumoral injection, given&#xD;
        either alone or combined with 2.5 Gy focal XRT.&#xD;
  &#xD;
        A course (cycle) of SIRPant-M is prepared from a single mononuclear apheresis, and comprises&#xD;
        3 equal ITI doses, administered at 2-day intervals. A low dose (90x10^6 cells split over 3&#xD;
        injections) and a high dose (300x10^6 cells split over 3 injections) of SIRPant-M are&#xD;
        evaluated. In cohorts receiving supplemental radiation, each cell injection will be followed&#xD;
        by 2.5 Gy radiation directed at the injected tumor site (7.5 Gy total).&#xD;
  &#xD;
        Dose escalations will be staggered using the 3+3 Phase 1 design, and safety will be monitored&#xD;
        by the Safety Review Committee (SRC). The SRC may direct additional- or intermediate dose&#xD;
        levels to be evaluated, as guided by emerging data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>Enrollment will begin with Cohort 1, Group 1 (SIRPant-M monotherapy, low dose). Upon approval from the SRC after Cohort 1, Group 1 review, enrollment in Cohort 1, Group 2 (SIRPant-M coupled with XRT, low dose) and Cohort 2, Group 3 (SIRPant-M monotherapy, high dose) will open. Upon approval from the SRC after Cohort 1, Group 2 and Cohort 2, Group 3 review, enrollment in Cohort 2, Group 4 (SIRPant-M coupled with XRT, high dose) will open.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)</measure>
      <time_frame>Day -42 through Day 364</time_frame>
      <description>Includes evaluation of frequency and severity of AEs, serious adverse events (SAEs), TEAEs, and adverse events of special interest (AESIs), including injection site reactions and abnormalities in clinical laboratory assessments, vital signs, or physical examination findings. Graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT</measure>
      <time_frame>Day 1 through Day 364</time_frame>
      <description>Based on review of safety, pharmacodynamic, and efficacy data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>Day 1 through Day 364</time_frame>
      <description>Based on number of participants with complete response (CR) and partial response (PR). Determined by positron emission tomography/computed tomography (PET/CT) and evaluated per the Lugano classification.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Refractory Non-Hodgkin Lymphoma</condition>
    <condition>Relapsed Non-Hodgkin Lymphoma</condition>
    <arm_group>
      <arm_group_label>SIRPant-M (90×10^6 cells)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SIRPant-M Monotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SIRPant-M (90×10^6 cells) coupled with focal XRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SIRPant-M (300×10^6 cells)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SIRPant-M Monotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SIRPant-M (300×10^6 cells) coupled with focal XRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>SIRPant-M</intervention_name>
      <description>Autologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection</description>
      <arm_group_label>SIRPant-M (300×10^6 cells)</arm_group_label>
      <arm_group_label>SIRPant-M (300×10^6 cells) coupled with focal XRT</arm_group_label>
      <arm_group_label>SIRPant-M (90×10^6 cells)</arm_group_label>
      <arm_group_label>SIRPant-M (90×10^6 cells) coupled with focal XRT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>External-beam radiotherapy (XRT)</intervention_name>
      <description>Radiotherapy given by external beam</description>
      <arm_group_label>SIRPant-M (300×10^6 cells) coupled with focal XRT</arm_group_label>
      <arm_group_label>SIRPant-M (90×10^6 cells) coupled with focal XRT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult, defined as age ≥ 18 (at screening), who are willing and able to provide&#xD;
               informed consent&#xD;
  &#xD;
            2. Must have relapsed/refractory lymphoma, received at least 2 lines of systemic therapy,&#xD;
               be ineligible or inappropriate for other treatment regimens known to have curative&#xD;
               potential, and must have recovered from the acute toxic effects of all prior oncologic&#xD;
               therapy of curative intent (except alopecia)&#xD;
  &#xD;
            3. Histologically or cytologically confirmed diagnosis of NHL, any one of the below:&#xD;
  &#xD;
                 1. Eligible for SIRPant-M monotherapy or SIRPant-M plus focal XRT combination&#xD;
                    therapy: Diffuse large B-cell lymphoma and cutaneous T-cell lymphoma (CTCL),&#xD;
                    including mycosis fungoides (MF), Sezary Syndrome, anaplastic large cell lymphoma&#xD;
                    (ALCL), lymphomatoid papulosis; adult T-cell leukemia/lymphoma (ATLL); peripheral&#xD;
                    T cell lymphoma; and angioimmunoblastic T cell lymphoma&#xD;
  &#xD;
                 2. Eligible for SIRPant-M monotherapy only: Cutaneous B-cell lymphoma, including&#xD;
                    primary cutaneous follicle center lymphoma and primary cutaneous marginal zone&#xD;
                    B-cell, leg type; follicular center lymphoma; chronic lymphocytic leukemia (CLL)&#xD;
                    /small lymphocytic lymphoma (SLL); mantle cell lymphoma (MCL); nodal marginal&#xD;
                    zone B-cell lymphoma&#xD;
  &#xD;
            4. Must have at least one accessible lymph node or cutaneous or subcutaneous lesion of&#xD;
               1.5 to 5 cm in one dimension as measured by computed tomography (CT) or positron&#xD;
               emission tomography/computed tomography (PET/CT) or ultrasound for ITI by an&#xD;
               interventional radiologist or other appropriately qualified and trained personnel,&#xD;
               which presents a low risk for complications as determined by the Interventional&#xD;
               Radiologist and the Principal Investigator. The target lesion must not have been&#xD;
               previously irradiated. Note that lesions in the vicinity of large vessels, and&#xD;
               tumor-encased large vessels are not considered low-risk. Additional caution should be&#xD;
               taken in patients with neck lesions and lesions connected to ulcerated skin or mucosal&#xD;
               surface. The target lesion must not be &gt;5 cm in any dimension.&#xD;
  &#xD;
            5. Must have a life expectancy &gt; 3 months; must also be confirmed within 7 days prior to&#xD;
               Day 1 of SIRPant-M ITI treatment&#xD;
  &#xD;
            6. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; must&#xD;
               also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment&#xD;
  &#xD;
            7. Must have hematologic values as follows: hemoglobin (Hgb) &gt; 8 g/dL, ANC &gt; 500 /mm3,&#xD;
               monocyte counts ≥ 200/μL, and platelets &gt; 50,000/µL; must also be confirmed within 7&#xD;
               days prior to Day 1 of SIRPant-M ITI treatment&#xD;
  &#xD;
            8. Must have adequate renal and hepatic function as follows:&#xD;
  &#xD;
                 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) &lt;3× the upper&#xD;
                    limit of normal (ULN) (unless attributed to leukemic involvement or required&#xD;
                    concomitant medication)&#xD;
  &#xD;
                 2. Calculated creatinine clearance ≥60 milliliter per minute (mL/min) calculated&#xD;
                    with Cockcroft-Gault formula&#xD;
  &#xD;
                 3. Bilirubin ≤1.5×ULN, unless secondary to Gilbert's Syndrome.&#xD;
  &#xD;
               Must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment.&#xD;
  &#xD;
            9. Cardiac function: Must be American Heart Association (AHA) class 1 without significant&#xD;
               limitation of physical activity; must also be confirmed within 7 days prior to Day 1&#xD;
               of SIRPant-M ITI treatment.&#xD;
  &#xD;
           10. Must not be pregnant or planning to become pregnant. A negative urine or serum&#xD;
               pregnancy test result is required for persons of reproductive potential within 72&#xD;
               hours prior to start of study treatment administration.&#xD;
  &#xD;
           11. All persons of reproductive potential must agree to use an effective contraceptive&#xD;
               method during study participation and for a minimum of 90 days after study treatment.&#xD;
  &#xD;
                 1. Biologically female: is premenarcheal, surgically sterile (post hysterectomy,&#xD;
                    bilateral salpingectomy, or bilateral oophorectomy), postmenopausal (&gt;12 months&#xD;
                    of amenorrhea without alternative medical causes), or, if of reproductive&#xD;
                    potential, is using a highly effective method of contraception (combined&#xD;
                    estrogen/progestogen or progestogen-only hormonal contraceptives associated with&#xD;
                    inhibition of ovulation, intrauterine device [IUD], intrauterine&#xD;
                    hormone-releasing system [IUS], bilateral tubal occlusion/ligation, vasectomized&#xD;
                    partner[s], double barrier method [male condom with either cap, diaphragm, or&#xD;
                    sponge with spermicide], or true abstinence of heterosexual intercourse when this&#xD;
                    is in line with the preferred and usual lifestyle of the person [periodic&#xD;
                    abstinence, eg, calendar, ovulation, symptom-thermal, post-ovulation methods, and&#xD;
                    withdrawal are not acceptable methods of contraception]), and agrees to continued&#xD;
                    use of this method until 90 days after end of study treatment&#xD;
  &#xD;
                 2. Biologically male: is vasectomized and has received medical assessment of&#xD;
                    surgical success, has undergone bilateral orchidectomy, or agrees to use an&#xD;
                    approved method of contraception (true abstinence of heterosexual intercourse&#xD;
                    when this is in line with the preferred and usual lifestyle of the person, double&#xD;
                    barrier method [male condom with either cap, diaphragm, or sponge with&#xD;
                    spermicide], partner's use of a highly effective method of contraception sterile,&#xD;
                    partner is postmenopausal, or partner is surgically sterile) and agrees to use&#xD;
                    this method until 90 days after study treatment&#xD;
  &#xD;
           12. In the opinion of the Investigator, must be willing and able to comply with the&#xD;
               protocol for the duration of the study including undergoing treatment, the required&#xD;
               tumor tissue biopsy procedures, scheduled visits and examinations, and including&#xD;
               follow up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Must not have received prior ITI therapy&#xD;
  &#xD;
            2. Must not have received ASCT or treatment with cellular therapy including CAR-T within&#xD;
               the prior 1 month; must not have received allogeneic stem cell transplantation within&#xD;
               prior 6 months and must have no active graft-versus-host disease (GVHD) or be under&#xD;
               active immunosuppression for GVHD.&#xD;
  &#xD;
            3. Must not have received prior systemic anti-cancer therapy within the past 14 days&#xD;
               before start of study cell therapy&#xD;
  &#xD;
            4. Must not have received IL-2 therapy within the last 6 months&#xD;
  &#xD;
            5. Must not have acquired immune defects such as human immunodeficiency virus (HIV)&#xD;
  &#xD;
            6. Must not have uncontrolled hypertension (systolic &gt;180 mmHg, diastolic &gt;100 mmHg)&#xD;
  &#xD;
            7. Must not have diagnosis of unclassifiable B cell lymphoma&#xD;
  &#xD;
            8. Must not have bleeding diathesis or abnormal values for prothrombin time (PT) or&#xD;
               activated partial thromboplastin time (aPTT), international normalized ratio (INR) &gt;&#xD;
               1.5× ULN&#xD;
  &#xD;
            9. Must not be receiving anti-platelet drugs that may present a risk for intratumor&#xD;
               injections&#xD;
  &#xD;
           10. Must not have pulmonary disease which, in the opinion of the Investigator, might&#xD;
               impair the patient's respiratory tolerance to moderate pulmonary fluid overload (eg,&#xD;
               interstitial lung disease, severe chronic obstructive pulmonary disease)&#xD;
  &#xD;
           11. Must not have known alcohol or drug abuse&#xD;
  &#xD;
           12. Must not have received an investigational agent within the past 30 days before start&#xD;
               of study cell therapy&#xD;
  &#xD;
           13. Must not require a chronic therapy with prednisone at a dose of or exceeding 10 mg/day&#xD;
               or equivalent or any other form of immunosuppressive therapy&#xD;
  &#xD;
           14. Must not have active central nervous system tumors or metastases&#xD;
  &#xD;
           15. Must not be ineligible to receive 2.5 Gy ×3 focal external-beam radiation therapy as&#xD;
               determined by the Radiation Oncologist and Principal Investigator (Cohort 1/Group 2,&#xD;
               Cohort 2/Group 4, and Cohort -1/Group 4 only)&#xD;
  &#xD;
           16. Must not have uncontrolled active viral hepatitis-B, -C, and/or -D infection&#xD;
  &#xD;
           17. Must not have received a live vaccine within 4 weeks of the baseline/screening visit&#xD;
  &#xD;
           18. Must not have active, uncontrolled autoimmune disease and/or history of autoimmune&#xD;
               diseases at high risk for relapse&#xD;
  &#xD;
           19. Must not have another malignancy or uncontrolled intercurrent illness, condition,&#xD;
               serious medical or psychiatric illness, or circumstance that, in the opinion of the&#xD;
               Investigator, could interfere with adherence to the study's procedures or&#xD;
               requirements, or otherwise compromise the study's objectives&#xD;
  &#xD;
           20. No active systemic infection; must also be confirmed on Day 1 prior to initiation of&#xD;
               ITI&#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>Jelle Kijlstra, MD, MBA</last_name>
      <role>Study Director</role>
      <affiliation>SIRPant Immunotherapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jelle Kijlstra, MD, MBA</last_name>
      <phone>610-321-3111</phone>
      <email>jkijlstra@sirpantimmunotx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>City of Hope</name>
        <address>
          <city>Duarte</city>
          <state>California</state>
          <zip>91010</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hackensack University Medical Center</name>
        <address>
          <city>Hackensack</city>
          <state>New Jersey</state>
          <zip>07601</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tatyana Feldman, MD</last_name>
      </contact>
    </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>
      <contact>
        <last_name>Paolo Strati, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Non-Hodgkin Lymphoma</keyword>
    <keyword>Relapsed/Refractory Non-Hodgkin Lymphoma</keyword>
    <keyword>Autologous cell therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967416
  org study id: SIRP01-1001
  nct id: NCT05967416
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this study is to test SIRPant-M, an autologous cell therapy, alone or in
        combination with focal external-beam radiotherapy in participants with relapsed or refractory
        non-Hodgkin's lymphoma (NHL). Two dose levels of SIRPant-M are being tested. The main
        question this study aims to answer is if SIRPant-M alone or in combination with radiotherapy
        is safe and well-tolerated.
  This is an open-label phase 1 study of SIRPant-M studied in serial cohorts either alone
        (monotherapy), or combined with low-dose focal external-beam radiotherapy (XRT) in patients
        with relapsed- or refractory Non-Hodgkin's lymphoma (NHL). Both B-cell and certain T-cell NHL
        (select PTCL; CTCL) are eligible. The primary objective of the study is to assess the safety
        and tolerability of autologous SIRPant-M, delivered by 3 intra-tumoral injection, given
        either alone or combined with 2.5 Gy focal XRT.
  
        A course (cycle) of SIRPant-M is prepared from a single mononuclear apheresis, and comprises
        3 equal ITI doses, administered at 2-day intervals. A low dose (90x10^6 cells split over 3
        injections) and a high dose (300x10^6 cells split over 3 injections) of SIRPant-M are
        evaluated. In cohorts receiving supplemental radiation, each cell injection will be followed
        by 2.5 Gy radiation directed at the injected tumor site (7.5 Gy total).
  
        Dose escalations will be staggered using the 3+3 Phase 1 design, and safety will be monitored
        by the Safety Review Committee (SRC). The SRC may direct additional- or intermediate dose
        levels to be evaluated, as guided by emerging data.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: Enrollment will begin with Cohort 1, Group 1 (SIRPant-M monotherapy, low dose). Upon approval from the SRC after Cohort 1, Group 1 review, enrollment in Cohort 1, Group 2 (SIRPant-M coupled with XRT, low dose) and Cohort 2, Group 3 (SIRPant-M monotherapy, high dose) will open. Upon approval from the SRC after Cohort 1, Group 2 and Cohort 2, Group 3 review, enrollment in Cohort 2, Group 4 (SIRPant-M coupled with XRT, high dose) will open.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)
  time frame: Day -42 through Day 364
  description: Includes evaluation of frequency and severity of AEs, serious adverse events (SAEs), TEAEs, and adverse events of special interest (AESIs), including injection site reactions and abnormalities in clinical laboratory assessments, vital signs, or physical examination findings. Graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
  measure: Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT
  time frame: Day 1 through Day 364
  description: Based on review of safety, pharmacodynamic, and efficacy data.
  measure: Objective response rate (ORR)
  time frame: Day 1 through Day 364
  description: Based on number of participants with complete response (CR) and partial response (PR). Determined by positron emission tomography/computed tomography (PET/CT) and evaluated per the Lugano classification.
  arm group label: SIRPant-M (90×10^6 cells)
  arm group type: Experimental
  description: SIRPant-M Monotherapy
  arm group label: SIRPant-M (90×10^6 cells) coupled with focal XRT
  arm group type: Experimental
  description: SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI
  arm group label: SIRPant-M (300×10^6 cells)
  arm group type: Experimental
  description: SIRPant-M Monotherapy
  arm group label: SIRPant-M (300×10^6 cells) coupled with focal XRT
  arm group type: Experimental
  description: SIRPant-M coupled with 2.5 Gy of focal XRT administered within 24 hours after the first ITI and within 3 hours before to 24 hours after the second and third ITI
  intervention type: Biological
  intervention name: SIRPant-M
  description: Autologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection
  arm group label: SIRPant-M (300×10^6 cells)
  arm group label: SIRPant-M (300×10^6 cells) coupled with focal XRT
  arm group label: SIRPant-M (90×10^6 cells)
  arm group label: SIRPant-M (90×10^6 cells) coupled with focal XRT
  intervention type: Radiation
  intervention name: External-beam radiotherapy (XRT)
  description: Radiotherapy given by external beam
  arm group label: SIRPant-M (300×10^6 cells) coupled with focal XRT
  arm group label: SIRPant-M (90×10^6 cells) coupled with focal XRT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jelle Kijlstra, MD, MBA
  role: Study Director
  affiliation: SIRPant Immunotherapeutics
  last name: Jelle Kijlstra, MD, MBA
  phone: 610-321-3111
  email: jkijlstra@sirpantimmunotx.com
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Non-Hodgkin
  sharing ipd: No