Condition: Acute Lymphoid Leukemia · Acute Lymphoblastic Leukemia · Sponsor: University of Colorado, Denver
This open-label, single arm Phase 1/1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 for apheresis, treatment with lymphodepleting chemotherapy, and UCD19 CAR T cell infusion. Patients will be assessed for DLTs (within 42 days after CAR T infusion) to determine a maximum tolerated dose (MTD), duration of B cell aplasia, overall response rate (at 1-3-, 6- and 12-months), and overall survival and event free survival (at 12- and 24- months) post UCD19 CAR T infusion. After the initial dose escalation phase, an additional 12 participants will be enrolled in the dose expansion at the MTD to determine preliminary efficacy.
This description comes directly from the study's public registry record.
Derek Schatz · 17208480628 · derek.schatz@cuanschutz.edu
Mathew Angelos, MD
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| University of Colorado Hospital | Aurora, Colorado, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05535855