RecruitingPhase 1NCT06544265
SynKIR-310 for Relapsed/Refractory B-NHL
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
Sponsor
Verismo Therapeutics
Enrollment
18 participants
Start Date
Nov 1, 2024
Study Type
INTERVENTIONAL
Conditions
Diffuse Large B Cell LymphomaHigh-grade B-cell LymphomaDLBCL - Diffuse Large B Cell LymphomaMantle Cell LymphomaFollicular LymphomaRefractory Non-Hodgkin LymphomaMarginal Zone LymphomaIndolent B-Cell Non-Hodgkin LymphomaB-cell LymphomaNHL, AdultHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedLarge B-cell LymphomaRelapsed Non Hodgkin LymphomaNon-hodgkin Lymphoma,B CellPrimary Mediastinal Large B-cell Lymphoma (PMBCL)DLBCLFollicular Lymphoma Grade 3BT-Cell/Histiocyte Rich LymphomaHGBL With MYC and BCL2 and/or BCL6 RearrangementsFollicular Lymphoma Grade 3Aggressive B-Cell Non-Hodgkin LymphomaEpstein-Barr Virus Positive DLBCL, NosDLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic InflammationMarginal Zone Splenic Lymphoma
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
BIOLOGICALSynKIR-310
Autologous T Cells transduced with CD19 KIR-CAR
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06544265
Related Trials
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
NCT0459464227 locations
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT0663458949 locations
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
NCT05100862277 locations
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
NCT05006716120 locations
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
NCT06742996149 locations