Trials / Recruiting
RecruitingNCT06544265
SynKIR-310 for Relapsed/Refractory B-NHL
A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Verismo Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed/refractory B-NHL.
Detailed description
This is a Phase 1, FIH, multicenter, open-label study of a single infusion of SynKIR-310 in participants with relapsed/refractory B-NHL. Up to 36 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study. Up to 4 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-310. Doses will be escalated across up to 4 cohorts to determine a Recommended Phase 2 Dose (RP2D). Once the RP2D has been determined, a dose expansion group will enroll additional participants regardless of subtypes of B-NHL at the RP2D to further characterize the safety, feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL.
Conditions
- B Cell Lymphoma
- NHL, Adult
- Mantle Cell Lymphoma
- Relapsed Non-Hodgkin Lymphoma
- Refractory Non-Hodgkin Lymphoma
- Aggressive B-Cell Non-Hodgkin Lymphoma
- Indolent B-Cell Non-Hodgkin Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- DLBCL - Diffuse Large B Cell Lymphoma
- HGBL With MYC and BCL2 and/or BCL6 Rearrangements
- High-grade B-cell Lymphoma
- Diffuse Large B Cell Lymphoma
- Large B-cell Lymphoma
- T-Cell/Histiocyte Rich Lymphoma
- Non-hodgkin Lymphoma,B Cell
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Epstein-Barr Virus Positive DLBCL, Nos
- Follicular Lymphoma Grade 3B
- DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation
- High Grade B-Cell Lymphoma, Not Otherwise Specified
- Follicular Lymphoma Grade 3
- Marginal Zone Splenic Lymphoma
- DLBCL
- Waldenstrom Macroglobulinemia
- Waldenstrom Macroglobulinaemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SynKIR-310 | Autologous T Cells transduced with CD19 KIR-CAR |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2028-09-01
- Completion
- 2028-12-01
- First posted
- 2024-08-09
- Last updated
- 2026-04-14
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06544265. Inclusion in this directory is not an endorsement.