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.
Primary:
- To evaluate the safety of a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non- Hodgkin Lymphoma (B-NHL).
- To determine the recommended Phase 2 dose (RP2D) of SynKIR-310 in participants with relapsed/refractory B-NHL.
Secondary:
- To evaluate feasibility of administering a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non-Hodgkin Lymphoma (B-NHL).
- To evaluate preliminary efficacy measures of SynKIR-310 in participants with relapsed/refractory B-NHL.
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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