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NCT05967416
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
Phase 1 trial testing SIRPant-M in Refractory Non-Hodgkin Lymphoma in 24 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | SIRPant Immunotherapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 17 January 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- SIRPant-M — full drug profile →
- External-beam radiotherapy (XRT)
Conditions studied
- Refractory Non-Hodgkin Lymphoma — all drugs for Refractory Non-Hodgkin Lymphoma →
- Relapsed Non-Hodgkin Lymphoma — all drugs for Relapsed Non-Hodgkin Lymphoma →
Sponsor
SIRPant Immunotherapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Refractory Non-Hodgkin Lymphoma or Relapsed Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Cell-Based Therapies for Solid Tumors: Challenges and Advances.
Smolarska A, Kokoszka Z, Naliwajko M, Strupczewska J, et al · · 2025 · cited 4× · PMID 40564987 · DOI 10.3390/ijms26125524 -
Incorporating Immunotherapy with Radiotherapy for Lymphomas.
Strati P, Spiotto MT. · · 2023 · cited 2× · PMID 39917366 · DOI 10.3390/lymphatics1030018 -
Roles of the phagocytosis checkpoint in radiotherapy.
Kui Y, Tong F, Zhang R, Wang J, et al · · 2025 · PMID 40835598 · DOI 10.1038/s41419-025-07921-5
Verify or expand the search:
- PubMed search for NCT05967416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Refractory Non-Hodgkin Lymphoma
Currently open trials in the same condition.
- NCT07166419 — Anti-CD19/20/22 Chimeric Antigen Receptor T Cells (TriCAR19.20.22 T Cells) for the Treatment of Relapsed or Refractory N · Phase 1 · recruiting
- NCT05077527 — Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
- NCT06550141 — Emapalumab Prevention of CAR-T Cell Associated Toxicities · Phase 2 · recruiting
- NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
- NCT06026319 — CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05967416 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SIRPant Immunotherapeutics, Inc.
- Last refreshed: 17 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05967416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing