Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310
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
This study is testing a new treatment called SynKIR-310 to see if it can help adults with relapsed or refractory B-cell lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Verismo Therapeutics Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Trial ID | NCT06544265 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory B-NHL who have received prior CAR T therapy or are unable to receive it.
Not a fit: Patients who have not undergone at least two prior lines of therapy or those with active graft versus host disease after allogeneic stem cell transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with difficult-to-treat B-cell lymphoma.
How similar studies have performed: While this approach is novel, similar studies targeting B-NHL have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Denver, Colorado and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.