Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSIRPant Immunotherapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
SIRPant-M
Biological/VaccineAutologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection
External-beam radiotherapy (XRT)
RadiationRadiotherapy given by external beam to the IT-injected lesion only
Treatment groups
24 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: SIRPant-M (90×10^6 cells)Experimental treatment 1 intervention
Group B: SIRPant-M (90×10^6 cells) with focal XRTExperimental treatment 2 interventions
Group C: SIRPant-M (300×10^6 cells)Experimental treatment 1 intervention
Group D: SIRPant-M (300×10^6 cells) with focal XRTExperimental treatment 2 interventions
Group E: SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosingExperimental treatment 2 interventions
Group F: SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Day -42 through Day 364Secondary outcomes
1
Recommended phase 2 dose of autologous SIRPant-M +/- 2.5 Gy ×3 focal XRT
Based on review of safety, pharmacodynamic, and efficacy data.
Time frame
Day 1 through Day 3642
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.
Time frame
Day 1 through Day 364Sponsors and contacts
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Source ClinicalTrials.gov