UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1

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 su

Trial Details

NCT ID

NCT05535855

Phase

PHASE1

Sponsor

University of Colorado, Denver

Status

RECRUITING

Cancer Type

Leukemia

Interventions

• CD19 Directed CAR T Cell

Locations (sample)

• Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

• Age: ≥ 18 years of age with no upper age limit
• ECOG Performance Status ≤ 2
• Confirmed B-cell ALL in first complete morphologic remission
• MRD positivity as defined by:

For full eligibility, visit ClinicalTrials.gov.

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