Actively Recruiting
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
Led by University of Colorado, Denver · Updated on 2026-03-11
29
Participants Needed
1
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit
- ECOG Performance Status of 2 or less
- Confirmed diagnosis of B-cell acute lymphoblastic leukemia in first complete remission
- Measurable residual disease (MRD) positivity as defined by specific laboratory criteria
- Peripheral blood CD3 count greater than 0.15 x 10^6 cells/mL within 21 days prior to apheresis
- Stable toxicities from prior therapy, recovered to Grade 2 or less except for non-clinically significant toxicities
- Adequate organ function including neutrophil count, platelet count, kidney, liver, heart, and lung function within specified limits
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during the study and for 12 months after UCD19 infusion
- Ability to provide informed consent and consent to long-term follow-up
You will not qualify if you...
- Previous treatment with CAR T therapy
- Relapsed or refractory B-cell acute lymphoblastic leukemia or evidence of MRD-negative remission relapse
- Diagnosis of mixed phenotype acute leukemia or Burkitt's lymphoma
- Not in hematologic remission at enrollment (more than 5% blasts)
- Active central nervous system disease symptoms or MRI evidence at screening
- History of malignancy unless disease-free for at least 3 years, excluding some skin or in situ cancers
- Uncontrolled infections requiring antimicrobial treatment (except simple UTI or pharyngitis under treatment)
- Known HIV, hepatitis B, or hepatitis C infection
- Recent significant cardiac disease within 12 months or lymphoma involving the heart
- Venous thrombosis or embolism not stable on anticoagulation
- Any medical condition likely to interfere with study assessments
- History of severe allergic reaction to study agents
- Females planning pregnancy during the study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
CONTACT
M
Mathew Angelos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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