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RecruitingNCT06544265Updated Apr 14, 2026

SynKIR-310 for Relapsed/Refractory B-NHL

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

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lymphoma, B-Cell

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • Previously treated with any investigational agent within 30 days prior to screening.
  • Any previous or concurrent malignancy, with the following exceptions:

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.

  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    SynKIR-310

    Single dose IV administration of SynKIR-310

    Biological: SynKIR-310

Interventions

  • BiologicalSynKIR-310

    Autologous T Cells transduced with CD19 KIR-CAR

06

What researchers measure

Primary outcomes

  1. 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

  2. Recommended Phase 2 Dose (RP2D)

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

    Time frame: Up to 24 months

Secondary outcomes

  1. Feasibility of SynKIR-310

    Number of enrolled patients who pass screening but do not receive SynKIR-310

    Time frame: Up to 24 months

  2. Preliminary efficacy : Objective response rate (ORR)

    Percentage of patients with a complete or partial response determined by Investigator

    Time frame: Up to 24 months

  3. Preliminary efficacy: Complete response rate (CR)

    Percentage of patients with a Complete Response determined by Investigator

    Time frame: Up to 24 months

  4. 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

  5. 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

07

Study locations

5 of 5 sites recruiting
  • Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
    Denver, Colorado 80218, United States
    Recruiting
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322, United States
    Recruiting
  • The University of Kansas Cancer Center
    Fairway, Kansas 66205, United States
    • Nurse Navigator · Contact · CTNurseNav@kumc.edu · 913-945-7552
    • Joseph McGuirk, DO · Principal investigator
    Recruiting
  • Rutgers Cancer Institute
    New Brunswick, New Jersey 08902, United States
    • Hem/Onc Clinical Trial Lab Manager · Contact · tn293@cinj.rutgers.edu · 732-235-7315
    • Matthew Matasar, MD · Principal investigator
    Recruiting
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06544265
Lead sponsor
Verismo Therapeutics
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Nov 1, 2024
Primary completion
Sep 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 14, 2026

Study contacts

Physician Connect
Contact
physician.connect@verismotherapeutics.com
267-392-6847 ext. 267-392-6847
Laura A Johnson, PhD
study chair · Verismo Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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