Actively Recruiting
Phase 1/1b Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adults With B-Cell Acute Lymphoblastic Leukemia With MRD Positivity at First Remission
Led by University of Colorado, Denver · Updated on 2026-03-11
29
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of CD19 directed CAR T cell therapy (UCD19 CAR T) in adults with B-cell acute lymphoblastic leukemia (B-ALL) who are in their first complete remission but still have minimal residual disease (MRD) positivity. This Phase 1/1b trial aims to find the maximum tolerated dose and to observe the treatment's effects on survival and disease response over time. The trial started in January 2024 and is sponsored by the University of Colorado, Denver. Participants will first undergo apheresis to collect cells, followed by lymphodepleting chemotherapy. After chemotherapy, patients will receive an infusion of UCD19 CAR T cells. The infusion may be delayed up to seven days after chemotherapy if needed to resolve toxicities or for product release. The study includes a dose escalation phase with 10 patients, followed by a dose expansion phase with 12 additional participants treated at the maximum tolerated dose. During the study, participants will be monitored closely for adverse events, dose limiting toxicities, and treatment response at multiple time points up to 24 months after infusion. Assessments include blood tests, organ function checks, and weekly evaluations until 42 days post CAR T infusion. Participants must stay within one hour of the treatment center for at least four weeks after infusion for monitoring. The main outcomes measured are safety, overall response rate, survival, and event-free survival.
CONDITIONS
Brief 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 B-cell acute lymphoblastic leukemia in first complete remission
- Minimal residual disease positivity as defined by study criteria
- Peripheral blood CD3 count above 0.15 x 10^6 cells/mL within 21 days before apheresis
- Stable and recovered toxicities from prior therapy to Grade 2 or less
- Adequate organ function including blood counts, kidney, liver, heart, and lung function as specified
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during the study and for 12 months after CAR T infusion
- Ability to give informed consent and agree to long-term follow-up protocol
You will not qualify if you...
- Previous CAR T cell therapy
- Relapsed or refractory B-cell acute lymphoblastic leukemia or MRD after prior negative remission
- Mixed phenotype acute leukemia or Burkitt's lymphoma
- Not in hematological remission (more than 5% blasts) at enrollment
- Active central nervous system disease or detectable CNS disease on MRI at screening
- History of other malignancies unless disease-free for at least 3 years
- Uncontrolled infections requiring antimicrobial treatment
- Known HIV or hepatitis B or C infection
- Significant cardiac disease within 12 months before enrollment
- Venous thrombosis or embolism not on stable anticoagulation
- Any medical condition interfering with safety or efficacy assessments
- History of severe immediate allergic reactions to study agents
- Females planning pregnancy during the study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive lymphodepleting chemotherapy before CAR T cell infusion.
1 visit for chemotherapy and monitoring
Duration - Single infusion with monitoring up to 42 days post-infusion
Participants receive infusion of UCD19 CAR T cells following chemotherapy, with possible delay of up to 7 days for recovery or product release.
1 infusion visit and multiple follow-up visits during first 42 days
Duration - Up to 24 months
Participants are monitored for safety and efficacy outcomes including adverse events, dose limiting toxicities, and response assessments up to 24 months after infusion.
Visits at 1, 3, 6, 12, and 24 months post-infusion
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
M
Mathew Angelos, MD
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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