Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety, feasibility, and preliminary efficacy of a single intravenous dose of SynKIR-310 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The study will enroll up to 18 participants, who will be divided into cohorts to assess different dosing levels. Following the determination of a recommended dose, additional participants will be treated to further evaluate the treatment's effects. The trial aims to provide insights into the potential of SynKIR-310 as a new therapeutic option for this challenging condition.

Why it matters

Who can join: the full rules

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:

* 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.

Where it's running

• Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
  Denver, Colorado, United States Recruiting
• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• The University of Kansas Cancer Center
  Fairway, Kansas, United States Recruiting
• Rutgers Cancer Institute
  New Brunswick, New Jersey, United States Recruiting
• Abramson Cancer Center of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Physician Connect
• Email: physician.connect@verismotherapeutics.com
• Phone: 267-392-6847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.