SynKIR-310 for Relapsed/Refractory B-NHL

Launched by VERISMO THERAPEUTICS · Aug 5, 2024

Keywords

ClinConnect Summary

The SynKIR-310 trial is a research study aimed at evaluating a new treatment called SynKIR-310 for adults with certain types of B-cell lymphoma that have not responded to previous therapies or have returned after treatment. This is the first time this treatment is being tested in humans, and the main goals are to check how safe it is, how well it works, and how easy it is to give as an intravenous (IV) dose.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of B-cell lymphoma. You should have already tried at least two previous treatments without success, or you may have previously received a type of therapy called CAR T-cell treatment but were unable to get it again. Participants will need to have measurable disease, meaning there must be signs of lymphoma present that can be tracked. During the trial, participants can expect close monitoring for safety, and they will need to meet specific health criteria to ensure they are suitable for the study. If you or a loved one might be interested, please discuss this trial with your healthcare team to see if it could be a good option.

Gender

ALL

Eligibility 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.
• • Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014).
• • 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.
• • 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.
• • 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.
• • Known immunodeficiency disease.
• • 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.