SynKIR-310 for Relapsed/Refractory B-NHL

This study is testing a new treatment called SynKIR-310 for adults with B-cell non-Hodgkin lymphoma (B-NHL) that has come back (relapsed) or hasn't responded to other treatments (refractory). SynKIR-310 is a type of CAR T-cell therapy, where your own immune cells are specially modified to fight cancer. The main goals of this first-in-human study are to see how safe SynKIR-310 is and to find the best dose. You may be able to join if you are 18 or older, have B-NHL, and have already had at least two other treatments, including or considering CAR T-cell therapy. The study plans to enroll up to 36 participants.

Study design
This is a Phase 1, first-in-human, open-label study, meaning all participants will receive SynKIR-310. Up to 36 participants will be enrolled to evaluate safety and determine the recommended dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 24 months after receiving the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06544265

SynKIR-310 for Relapsed/Refractory B-NHL

Recruiting
PHASE1Ages 18+InterventionalTreatment
Verismo Therapeutics
~36 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:SynKIR-310

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the safety of SynKIR310
Measured over Up to 24 months
+1 more outcome measured
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

NCT06544265

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jerseystudy coordinator listed

    Recruiting

  • The University of Kansas Cancer Center

    Fairway, Kansasstudy coordinator listed

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Laura A Johnson, PhD · STUDY_CHAIR · Verismo Therapeutics

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Eligibility criteria

Inclusion

Adult 18 years of age and older.
Histologically confirmed diagnosis of B-NHL before enrollment.
Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial
Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion

Previously treated with any investigational agent within 30 days prior to screening.
Any previous or concurrent malignancy, with the following exceptions:
Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis
Known immunodeficiency disease , with the exception of hypoglobulinemia
History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
Any active uncontrolled systemic fungal, bacterial or viral infection.
  • Evaluate the safety of SynKIR310Up to 24 months

    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

  • Recommended Phase 2 Dose (RP2D)Up to 24 months

    All available data from dose escalation cohorts will be evaluated to determine RP2D