Actively Recruiting
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
Led by Verismo Therapeutics · Updated on 2026-04-14
36
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and initial effects of a single intravenous dose of SynKIR-310 in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This first-in-human Phase 1 trial includes up to 36 participants with various B-NHL subtypes to better understand how this treatment works in this patient group. SynKIR-310 is an autologous T cell therapy modified with CD19 KIR-CAR, aiming to explore its potential in cases where previous treatments have failed or been declined. Participants will receive one intravenous infusion of SynKIR-310. The study involves up to four groups with increasing doses to find the best dose for further study, called the Recommended Phase 2 Dose (RP2D). After determining the RP2D, additional participants will receive this dose to gather more information on safety, feasibility, and initial response to treatment. Throughout the study, participants will be monitored for up to 24 months to assess safety and treatment effects. Researchers will evaluate response rates, duration of response, and how the body processes SynKIR-310. Regular assessments will include disease measurements, physical exams, and laboratory tests. This close monitoring helps understand how well the treatment is tolerated and its impact on lymphoma over time.
CONDITIONS
Brief Title
SynKIR-310 for Relapsed/Refractory B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age and older
- Histologically confirmed diagnosis of B-cell Non-Hodgkin Lymphoma before enrollment
- Must have received prior CAR T therapy or be unwilling/unable to receive prior CAR T
- Must have refractory or relapsed disease after at least 2 prior lines of therapies
- If relapsed/refractory after autologous stem cell transplant, must have undergone transplant at least 6 months prior
- If relapsed/refractory after allogeneic stem cell transplant, must have undergone transplant at least 6 months prior without graft versus host disease and expected to remain off immunosuppressive therapy during trial
- Measurable disease at enrollment per lymphoma response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Treated with any investigational agent within 30 days prior to screening
- Previous or concurrent malignancy except certain treated skin cancers, carcinoma-in-situ, or other malignancies in remission for specified time periods
- Use of systemic immunosuppressive drugs within 4 weeks prior to study entry or anticipated use through study end, except non-T cell targeting agents before leukapheresis
- Known immunodeficiency disease except hypoglobulinemia
- History or presence of active or relevant central nervous system disorders unless recovered/remission for at least 2 years
- Uncontrolled hypertension or serious cardiac conditions within 6 months prior to study entry
- Any active uncontrolled systemic fungal, bacterial, or viral infection
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up up to 24 months
Participants receive a single infusion of SynKIR-310, autologous T cells transduced with CD19 KIR-CAR.
1 infusion visit and multiple follow-up visits over 24 months
Trial Site Locations
Total: 5 locations
1
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08902
Actively Recruiting
5
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Physician Connect
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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