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UCD19 CAR T Therapy for B-ALL with MRD Positivity

This study is testing a treatment called UCD19 CAR T cells for adults with B-cell Acute Lymphoblastic Leukemia (B-ALL) who are in their first complete remission but still have minimal residual disease (MRD) positivity. MRD means a very small number of leukemia cells remain. The UCD19 CAR T cells are made from your own immune cells, modified to find and fight cancer. This study aims to see how safe UCD19 CAR T cells are and if they can help treat the leukemia. We will look at side effects and how well the treatment works over 12 and 24 months. You may be able to join if you are 18 or older, have B-ALL in first complete remission, and have MRD positivity.

Study design
This is an open-label, single-arm Phase 1/1b study. It plans to enroll 29 participants, with 10 in the initial phase.
What's involved
You would undergo apheresis (a procedure to collect your blood cells), receive chemotherapy to prepare your body, and then get the UCD19 CAR T cell infusion. You will be monitored for side effects for up to 30 days and for specific toxicities for 42 days after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for preliminary efficacy for 12 and 24 months after the UCD19 CAR T infusion.

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NCT05535855

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Colorado, Denver
~29 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:CD19 Directed CAR T Cell

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of UCD19 CAR T in Adults With B-ALL in first complete remission with MRD Positivity: occurrence and frequency of Adverse Events (AEs)
Measured over Up to 30 days after last day of study participation
+2 more outcomes measured

Conditions

Acute Lymphoid Leukemia
Acute Lymphoblastic Leukemia

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Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Mathew Angelos, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Derek Schatz
[email protected]
17208480628
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Disease restaging studies will be performed as clinically indicated but must be within 14 days prior to initiation of lymphodepletion.
Peripheral blood for CD3 count must be obtained within 21 days prior to apheresis and, therefore, is not applicable for determining lymphodepleting chemotherapy eligibility.
No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator. If these criteria are not met, measures will be taken to resolve the underlying condition(s). If successful, cells may be infused up to (and including) 7 days following the time of the planned infusion with no additional lymphodepletion. If the UCD19 CAR T Cell infusion is delayed greater than 7 days, lymphodepleting chemotherapy MAY be repeated. Prior to commencing a second round of lymphodepletion, participants must meet lymphodepletion criteria described above.
Disease classified as Ph+ B-ALL.
Must be past the DLT period (Day 42).
Platelet count \> 50,000/μL.
ANC \> 1000/μL.

Exclusion

Medical history and Baseline Abnormalities
Medical history (defined as ongoing medical conditions identified before the subject's first study-specific intervention (i.e., initiation of LD Chemotherapy on Day -5).
Baseline abnormalities refer to abnormal clinical findings (e.g., laboratory values, vital signs, ECG results, etc.) identified before the start of LD Chemotherapy that may or may not be related to the subject's underlying disease.
All medical history and baseline abnormalities should be entered in the eCRF. Events should be assessed within 30 days prior to enrollment until LD Chemotherapy. Grading per CTCAE v5.0 should reflect the patient's status at the time of LD Chemotherapy.
Physical exam
UCD19 CAR T Cells must have met release criteria.
Performance status determination (ECOG must be ≤ 2).
Participant remains clinically stable without evidence of vital sign instability.
Must not have ALT/SGPT and AST/SGOT \> 10x the ULN or bilirubin \>2x the ULN, (unless history of Gilberts syndrome where bilirubin must not be \>3x ULN).

What this trial measures

  • Safety of UCD19 CAR T in Adults With B-ALL in first complete remission with MRD Positivity: occurrence and frequency of Adverse Events (AEs)Up to 30 days after last day of study participation

    The occurrence and frequency of Adverse Events will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading criteria.

  • Safety of UCD19 CAR T in Adults With B-ALL in first complete remission with MRD Positivity: occurrence of Dose Limiting Toxicities (DLTs)42 days

    Adverse events that are at least possibly related to the UCD19 CAR T cells with onset within the first 42 days following UCD19 CAR T cell infusion and are ≥ Grade 3 in severity will be considered DLTs. With exception to hematological toxicity for subjects with normal, Grade 1 or Grade 2 Hematologic Parameters at baseline (independent of transfusion) and cytopenias NOT due to Bone Marrow Involvement by Disease. However, any Grade 4 hematological toxicity (i.e., neutropenia or thrombocytopenia with the exception of lymphopenia) persisting beyond 42 days after infusion will be considered a DLT unless toxicity is attributed to patient's underlying disease.

  • Preliminary efficacy of UCD19 CAR T infusion at the MTD in adult B-ALL patients at first complete remission with MRD positivity12 and 24 months

    Determine the Relapse Free Survival (RFS) rate post UCD19 CAR T infusion. RFS will be measured from the date of infusion of the UCD19 CAR T product to the time of relapse or death from any cause