SynKIR-310 for Relapsed/Refractory B-NHL
Purpose
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.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- 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. - 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SynKIR-310 |
Single dose IV administration of SynKIR-310 |
|
Recruiting Locations
Fairway 4271358, Kansas 4273857 66205
More Details
- Status
- Recruiting
- Sponsor
- Verismo Therapeutics
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 18 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study. 2 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 2 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.