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

Recruiting Phase 1 Interventional Study
Acute Lymphoid Leukemia Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
University of Colorado, Denver · Other
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age: ≥ 18 years of age with no upper age limit 2. ECOG Performance Status ≤ 2 3. Confirmed B-cell ALL in first complete morphologic remission 4. MRD positivity as defined by: 1. For Ph- ALL: \> 0.01% by FACS or \> 0 clonal sequences by NGS (clonoSEQ). MRD assessment for e…
Contacts

Derek Schatz

17208480628

derek.schatz@cuanschutz.edu

CONTACT

Mathew Angelos, MD

CONTACT