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
Apply to this trial

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

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

Related Studies