A Phase 1 interventional study of SynKIR-310 in B Cell Lymphoma, NHL, Adult and Mantle Cell Lymphoma, sponsored by Verismo Therapeutics. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Verismo Therapeutics · Phase 1, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's planned enrollment of 36 is close to the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Verismo Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \< 1.0 may also be permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Single dose IV administration of SynKIR-310
Biological: SynKIR-310
Autologous T Cells transduced with CD19 KIR-CAR
Evaluate the safety of SynKIR310
The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs). Presence of RCL-VSV-G
Time frame: Up to 24 months
Recommended Phase 2 Dose (RP2D)
All available data from dose escalation cohorts will be evaluated to determine RP2D
Time frame: Up to 24 months
Feasibility of SynKIR-310
Number of enrolled patients who pass screening but do not receive SynKIR-310
Time frame: Up to 24 months
Preliminary efficacy : Objective response rate (ORR)
Percentage of patients with a complete or partial response determined by Investigator
Time frame: Up to 24 months
Preliminary efficacy: Complete response rate (CR)
Percentage of patients with a Complete Response determined by Investigator
Time frame: Up to 24 months
Preliminary efficacy: Duration of response (DOR)
Time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause, determined by Investigator
Time frame: Up to 24 months
PK profile of SynKIR-310
To evaluate the patients who show CAR T persistence in blood (measured in the blood by quantitative polymerase chain reaction (PCR)) at multiple study time points following SynKIR-310 infusion
Time frame: Up to 24 months
Plan to share: No
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Verismo Therapeutics