Clinical Trial Details

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