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
SIRPant Immunotherapeutics, Inc.
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. The main question this study aims to answer is if SIRPant-M alone or in combination with radiotherapy is safe and well-tolerated.
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 com…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult, defined as age ≥ 18 (at screening), who are willing and able to provide informed consent 2. 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) 3. Histologically or cytologically confirmed diagnosis of NHL, any one of the below: 1. Eligible for SIRPant-M monotherapy or SIRPant-M plus focal XRT combination therapy:…
Interventions
- BiologicalSIRPant-M
Autologous activated macrophage cell therapy manufactured from peripheral blood mononuclear cells given by intratumoral injection
- RadiationExternal-beam radiotherapy (XRT)
Radiotherapy given by external beam to the IT-injected lesion only
Locations (3)
- City of HopeDuarte, California
- Hackensack University Medical CenterHackensack, New Jersey
- MD Anderson Cancer CenterHouston, Texas