A Phase 1 study evaluating SC291, a hypoimmune allogeneic CD19-directed CAR T cell therapy, in relapsed and/or refractory B-cell malignancies
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Lymphoma/CLL (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Lunning, Matthew
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05878184?term=NCT05878184&rank=1
Summary
Primary Objectives
Evaluate safety and tolerability of SC291
Dose-limiting toxicities (DLTs)
Treatment-emergent adverse events (TEAEs)
Treatment-related adverse events (TRAEs)
Targeted adverse events (TAEs)
Adverse Events of Special Interest (AESIs)
2.2. Secondary Objectives
Evaluate preliminary anti-tumor activity of SC291
Objective response
Duration of response (DOR)
Time to next treatment
Progression free survival (PFS)
Event free survival (EFS)
Overall survival (OS)
Evaluate cellular kinetics and persistence of SC291
Cellular kinetics (CK)-related parameters evaluated by CAR copy number (CAR VCN): peak observed in peripheral blood after administration (Cmax), time of first occurrence of maximum-observed concentration (Tmax), terminal disposition phase half-life (t1/2), last observed quantifiable concentration in peripheral blood (Clast), time of last observed quantifiable concentration in peripheral blood (days) (Tlast), area under the concentration-time curves (AUCs)
Evaluate host immunogenicity to SC291
Humoral immunogenicity assessment (anti-CD19-directed CAR)
2.3. Exploratory Objectives
Evaluate additional immunogenicity assessments for SC291
Cellular immune response assessment (ELISpot/T cell killing/NK cell killing)
Donor-specific antibody evaluation (donor-specific antibody [DSA]/antibody-dependent cellular cytotoxicity [ADCC]/complement-dependent cytotoxicity [CDC])
Explore correlation of on-study biomarkers with subject safety and outcomes
T cell, B cell, and other immune cell phenotypes (CAR T enumeration and Immunophenotyping)
T cell activation, expansion, effector function, and exhaustion (Immunophenotyping)
Cytokines and other CRS-related pharmacodynamic biomarkers (Cytokine profiling)
Expression levels of CD19-directed CAR, CD47, TCR, HLA I/II (CAR T enumeration and CD47 expression)
Immunogenicity and immune evasion
Explore impact of baseline donor characteristics and drug product attributes on subject safety, outcomes, and cellular kinetics
Product characteristics parameters including:
T cell and other immune cell phenotypes
T cell activation, expansion, effector function, and exhaustion
Expression levels of CD19-directed CAR, CD47, TCR, HLA I/II
Molecular immune landscape analysis
Explore markers of durable response to SC291 (dose expansion only)
Longitudinal circulating tumor DNA (ctDNA) assessment (minimum residual disease [MRD] negativity)
Evaluate time to treatment of SC291
Time from study enrollment to SC291 treatment
Time from study enrollment to LD chemotherapy
Time from start of LD chemotherapy to SC291 treatment