Refractory Non-Hodgkin LymphomaPhase 1NCT05967416
Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 1 study testing SIRPant-M and External-beam radiotherapy (XRT) in people with Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by SIRPant Immunotherapeutics, Inc. at 3 sites in United States.
Trial summary
The goal of this study is to test SIRPant-M (RB-1355) , 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma
- What is being tested?
- SIRPant-M and External-beam radiotherapy (XRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, defined as age ≥ 18 (at screening), who are willing and able to provide informed consent
- Must have relapsed/refractory lymphoma, received at least 2 lines of systemic therapy, be ineligible or inappropriate for other treatment regimens known to have curative potential, and must have recovered from the acute toxic effects of all prior oncologic therapy of curative intent (except alopecia)
- Histologically or cytologically confirmed diagnosis of NHL, any one of the below:
- Eligible for SIRPant-M monotherapy or SIRPant-M plus focal XRT combination therapy: Diffuse large B-cell lymphoma and cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF), Sezary Syndrome, anaplastic large cell lymphoma (ALCL), lymphomatoid papulosis; adult T-cell leukemia/lymphoma (ATLL); peripheral T cell lymphoma; and angioimmunoblastic T cell lymphoma
- Eligible for SIRPant-M monotherapy only: Cutaneous B-cell lymphoma, including primary cutaneous follicle center lymphoma and primary cutaneous marginal zone B-cell, leg type; follicular center lymphoma; chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL); mantle cell lymphoma (MCL); nodal marginal zone B-cell lymphoma
- Must have at least one accessible lymph node or cutaneous or subcutaneous lesion of 1.5 to 5 cm in one dimension as measured by computed tomography (CT) or positron emission tomography/computed tomography (PET/CT) or ultrasound for ITI by an interventional radiologist or other appropriately qualified and trained personnel, which presents a low risk for complications as determined by the Interventional Radiologist and the Principal Investigator. The target lesion must not have been previously irradiated. Note that lesions in the vicinity of large vessels, and tumor-encased large vessels are not considered low-risk. Additional caution should be taken in patients with neck lesions and lesions connected to ulcerated skin or mucosal surface. The target lesion must not be >5 cm in any dimension.
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- Must have a life expectancy > 3 months; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have hematologic values as follows: hemoglobin (Hgb) > 8 g/dL, ANC > 500 /mm3, monocyte counts ≥ 200/μL, and platelets > 50,000/µL; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
- Must have adequate renal and hepatic function as follows:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3× the upper limit of normal (ULN) (unless attributed to leukemic involvement or required concomitant medication)
- Calculated creatinine clearance ≥60 milliliter per minute (mL/min) calculated with Cockcroft-Gault formula
- Bilirubin ≤1.5×ULN, unless secondary to Gilbert's Syndrome.
- Must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment.
- Cardiac function: Must be American Heart Association (AHA) class 1 without significant limitation of physical activity; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment.
- Must not be pregnant or planning to become pregnant. A negative urine or serum pregnancy test result is required for persons of reproductive potential within 72 hours prior to start of study treatment administration.
- All persons of reproductive potential must agree to use an effective contraceptive method during study participation and for a minimum of 90 days after study treatment.
- Biologically female: is premenarcheal, surgically sterile (post hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), postmenopausal (>12 months of amenorrhea without alternative medical causes), or, if of reproductive potential, is using a highly effective method of contraception (combined estrogen/progestogen or progestogen-only hormonal contraceptives associated with inhibition of ovulation, intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral tubal occlusion/ligation, vasectomized partner[s], double barrier method [male condom with either cap, diaphragm, or sponge with spermicide], or true abstinence of heterosexual intercourse when this is in line with the preferred and usual lifestyle of the person [periodic abstinence, eg, calendar, ovulation, symptom-thermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception]), and agrees to continued use of this method until 90 days after end of study treatment
- Biologically male: is vasectomized and has received medical assessment of surgical success, has undergone bilateral orchidectomy, or agrees to use an approved method of contraception (true abstinence of heterosexual intercourse when this is in line with the preferred and usual lifestyle of the person, double barrier method [male condom with either cap, diaphragm, or sponge with spermicide], partner's use of a highly effective method of contraception sterile, partner is postmenopausal, or partner is surgically sterile) and agrees to use this method until 90 days after study treatment
- In the opinion of the Investigator, must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, the required tumor tissue biopsy procedures, scheduled visits and examinations, and including follow up
Who cannot join
- Must not have received prior ITI therapy
- Must not have received ASCT or treatment with cellular therapy including CAR-T within the prior 1 month; must not have received allogeneic stem cell transplantation within prior 6 months and must have no active graft-versus-host disease (GVHD) or be under active immunosuppression for GVHD.
- Must not have received prior systemic anti-cancer therapy within the past 14 days before start of study cell therapy
- Must not have received IL-2 therapy within the last 6 months
- Must not have acquired immune defects such as human immunodeficiency virus (HIV)
- Must not have uncontrolled hypertension (systolic >180 mmHg, diastolic >100 mmHg)
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- Must not have diagnosis of unclassifiable B cell lymphoma
- Must not have bleeding diathesis or abnormal values for prothrombin time (PT) or activated partial thromboplastin time (aPTT), international normalized ratio (INR) > 1.5× ULN
- Must not be receiving anti-platelet drugs that may present a risk for intratumor injections
- Must not have pulmonary disease which, in the opinion of the Investigator, might impair the patient's respiratory tolerance to moderate pulmonary fluid overload (eg, interstitial lung disease, severe chronic obstructive pulmonary disease)
- Must not have known alcohol or drug abuse
- Must not have received an investigational agent within the past 30 days before start of study cell therapy
- Must not require a chronic therapy with prednisone at a dose of or exceeding 10 mg/day or equivalent or any other form of immunosuppressive therapy
- Must not have active central nervous system tumors or metastases
- Must not be ineligible to receive 2.5 Gy ×3 focal external-beam radiation therapy as determined by the Radiation Oncologist and Principal Investigator (Cohort 1/Group 2, Cohort 2/Group 4, and Cohort -1/Group 4 only)
- Must not have uncontrolled active viral hepatitis-B, -C, and/or -D infection
- Must not have received a live vaccine within 4 weeks of the baseline/screening visit
- Must not have active, uncontrolled autoimmune disease and/or history of autoimmune diseases at high risk for relapse
- Must not have another malignancy or uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives
- No active systemic infection; must also be confirmed on Day 1 prior to initiation of ITI
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Kimberly Cornejo-Peril, 626-218-7361, kcornejoperil@coh.org
Christiane Querfeld, MD, PhD
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Elizabeth McCarthy, 412-860-6447, elizabethl.mccarthy@hmhn.org
Tatyana Feldman, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Laurel Deaton, 832-710-7753, fldeaton@mdanderson.org
Paolo Strati, MD
About this study
Official title: Phase 1 Study of Autologous SIRPα-low Macrophages (SIRPant-M) Administered by IT- Injection Alone or in Combination With Focal External-Beam Radiotherapy in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
The goal of this study is to test SIRPant-M (RB-1355) , 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.
Read the detailed description
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 (RB-1355) 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), an intermediate dose (300x10^6 cells split over 3 injections) and a high dose (600x10^6 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). At the highest dose level only, alternate day IT-dosing (Day 1, 3, 5) will be compared with Weekly IT-dosing (W1, 2, 3).
Patients with PR or sustained clinical benefit (at least SD) after 1 cycle may receive a 2nd cycle of treatment, using cells prepared and frozen following the initial apheresis.
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.
- Being tested
- SIRPant-M, External-beam radiotherapy (XRT)
- Keywords
- Non-Hodgkin Lymphoma, Relapsed/Refractory Non-Hodgkin Lymphoma, Autologous cell therapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRPant-MBiological
Autologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection
External-beam radiotherapy (XRT)Radiation
Radiotherapy given by external beam to the IT-injected lesion only
| Study group | Role | What they receive |
|---|---|---|
| SIRPant-M (90×10^6 cells) | Experimental | SIRPant-M Monotherapy (Single Agent) Receives: Biological: SIRPant-M |
| SIRPant-M (90×10^6 cells) with focal XRT | Experimental | 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 Receives: Biological: SIRPant-M; Radiation: External-beam radiotherapy (XRT) |
| SIRPant-M (300×10^6 cells) | Experimental | SIRPant-M Monotherapy (Single Agent) Receives: Biological: SIRPant-M |
| SIRPant-M (300×10^6 cells) with focal XRT | Experimental | 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 Receives: Biological: SIRPant-M; Radiation: External-beam radiotherapy (XRT) |
| SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosing | Experimental | 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 Receives: Biological: SIRPant-M; Radiation: External-beam radiotherapy (XRT) |
| SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosing | Experimental | 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 Receives: Biological: SIRPant-M; Radiation: External-beam radiotherapy (XRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)
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.
Measured: Day -42 through Day 364
Secondary outcomes (2)
Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT
Based on review of safety, pharmacodynamic, and efficacy data.
Measured: Day 1 through Day 364
Objective response rate (ORR)
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.
Measured: Day 1 through Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Jan 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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, intermediate 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 + XRT, intermediate cell dose) will open. Upon further approval from the SRC, Cohort 3, Groups 5 and 6 (high cell dose + XRT, alternate day- versus weekly IT-dosing) will enroll.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SIRPant Immunotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jelle Kijlstra, MD, MBA, Study director, BobcatBio, p/k/a SIRPant Immunotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967416
- Sponsor's protocol ID
- SIRP01-1001
- Status last verified
- Dec 2024
- First submitted
- 21 Jul 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Autologous SIRPα-low Macrophages (SIRPant-M) Administered by IT- Injection Alone or in Combination With Focal External-Beam Radiotherapy in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05967416
- Acronym / sponsor ID
- SIRP01-1001
- Keywords
- Non-Hodgkin Lymphoma, Relapsed/Refractory Non-Hodgkin Lymphoma, Autologous cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- SIRPant Immunotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test SIRPant-M (RB-1355) , 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.
Detailed description
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 (RB-1355) 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), an intermediate dose (300x10^6 cells split over 3 injections) and a high dose (600x10^6 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). At the highest dose level only, alternate day IT-dosing (Day 1, 3, 5) will be compared with Weekly IT-dosing (W1, 2, 3).
Patients with PR or sustained clinical benefit (at least SD) after 1 cycle may receive a 2nd cycle of treatment, using cells prepared and frozen following the initial apheresis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- 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, intermediate 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 + XRT, intermediate cell dose) will open. Upon further approval from the SRC, Cohort 3, Groups 5 and 6 (high cell dose + XRT, alternate day- versus weekly IT-dosing) will enroll.
| Arm | Type | Receives |
|---|---|---|
| SIRPant-M (90×10^6 cells) | Experimental | Biological: SIRPant-MSIRPant-M Monotherapy (Single Agent) |
| SIRPant-M (90×10^6 cells) with focal XRT | Experimental | Biological: SIRPant-M, Radiation: External-beam radiotherapy (XRT)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 |
| SIRPant-M (300×10^6 cells) | Experimental | Biological: SIRPant-MSIRPant-M Monotherapy (Single Agent) |
| SIRPant-M (300×10^6 cells) with focal XRT | Experimental | Biological: SIRPant-M, Radiation: External-beam radiotherapy (XRT)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 |
| SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosing | Experimental | Biological: SIRPant-M, Radiation: External-beam radiotherapy (XRT)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 |
| SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosing | Experimental | Biological: SIRPant-M, Radiation: External-beam radiotherapy (XRT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult, defined as age ≥ 18 (at screening), who are willing and able to provide informed consent
- Must have relapsed/refractory lymphoma, received at least 2 lines of systemic therapy, be ineligible or inappropriate for other treatment regimens known to have curative potential, and must have recovered from the acute toxic effects of all prior oncologic therapy of curative intent (except alopecia)
- Histologically or cytologically confirmed diagnosis of NHL, any one of the below:
- Must have at least one accessible lymph node or cutaneous or subcutaneous lesion of 1.5 to 5 cm in one dimension as measured by computed tomography (CT) or positron emission tomography/computed tomography (PET/CT) or ultrasound for ITI by an interventional radiologist or other appropriately qualified and trained personnel, which presents a low risk for complications as determined by the Interventional Radiologist and the Principal Investigator. The target lesion must not have been previously irradiated. Note that lesions in the vicinity of large vessels, and tumor-encased large vessels are not considered low-risk. Additional caution should be taken in patients with neck lesions and lesions connected to ulcerated skin or mucosal surface. The target lesion must not be >5 cm in any dimension.
- Must have a life expectancy > 3 months; must also be confirmed within 7 days prior to Day 1 of SIRPant-M ITI treatment
Key exclusion criteria (20 listed)
- Must not have received prior ITI therapy
- Must not have received ASCT or treatment with cellular therapy including CAR-T within the prior 1 month; must not have received allogeneic stem cell transplantation within prior 6 months and must have no active graft-versus-host disease (GVHD) or be under active immunosuppression for GVHD.
- Must not have received prior systemic anti-cancer therapy within the past 14 days before start of study cell therapy
- Must not have received IL-2 therapy within the last 6 months
- Must not have acquired immune defects such as human immunodeficiency virus (HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRPant-MAutologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection | Biological | SIRPant-M (300×10^6 cells), SIRPant-M (300×10^6 cells) with focal XRT, SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosing, SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosing, SIRPant-M (90×10^6 cells), SIRPant-M (90×10^6 cells) with focal XRT |
| External-beam radiotherapy (XRT)Radiotherapy given by external beam to the IT-injected lesion only | Radiation | SIRPant-M (300×10^6 cells) with focal XRT, SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosing, SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosing, SIRPant-M (90×10^6 cells) with focal XRT |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs)
Time frame: Day -42 through Day 364
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.
2 secondary outcomes
Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT
Time frame: Day 1 through Day 364
Objective response rate (ORR)
Time frame: Day 1 through Day 364
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jelle Kijlstra, MD, MBA study director
BobcatBio, p/k/a SIRPant Immunotherapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIRPant-M and External-beam radiotherapy (XRT) in people with Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by SIRPant Immunotherapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jelle Kijlstra, MD, MBA (206-909-1125, jkijlstra@bobcatbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs) (time frame: Day -42 through Day 364). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.