Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
SIRPant Immunotherapeutics, Inc.
Study ID
NCT05967416
Phase
PHASE1
Status
Recruiting
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Conditions

  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SIRPant-M — BIOLOGICAL
    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 Details

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.

Key Dates

First listed
Aug 1, 2023
Start date
Jan 17, 2024
Status verified
Dec 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SIRPant-M (90×10^6 cells)
    SIRPant-M Monotherapy (Single Agent)
  • Experimental: SIRPant-M (90×10^6 cells) with focal 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
  • Experimental: SIRPant-M (300×10^6 cells)
    SIRPant-M Monotherapy (Single Agent)
  • Experimental: SIRPant-M (300×10^6 cells) with focal 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
  • Experimental: SIRPant-M (600×10^6 cells) with focal XRT, alternate Day 1, 3, 5 IT-dosing
    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
  • Experimental: SIRPant-M (600×10^6 cells) coupled with focal XRT, weekly (W1, 2, 3) IT-dosing
    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

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAEs) and adverse events (AEs) [ Time Frame: Day -42 through Day 364 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Kimberly Cornejo-Peril
[email protected]
626-218-7361
Christiane Querfeld, MD, PhD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Elizabeth McCarthy
[email protected]
412-860-6447
Tatyana Feldman, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Laurel Deaton
[email protected]
832-710-7753
Paolo Strati, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAHackensack University Medical Center· Hackensack, NJMD Anderson Cancer Center· Houston, TX

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