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UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Phase 1/1b Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adult Patients With B-Cell Acute Lymphoblastic Leukemia (B-ALL) With Minimal Residual Disease (MRD) Positivity at First Complete Remission

NCT05535855•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 eligibility must be at least 28 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of multi-agent chemotherapy (≥ 3 systemic anti-leukemia chemotherapy agents).
•2. For Ph+ ALL: \> 0.01% by FACS, \> 0 clonal sequences by NGS (clonoSEQ), or less than complete molecular remission (undetectable BCR-ABL1 transcripts by RT-PCR assay with sensitivity of at least 1 in 100,000). MRD assessment for eligibility must be at least 57 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of a BCR-ABL1 directed tyrosine kinase inhibitor and at least one other systemic anti-leukemia chemotherapy agent.
•5. Peripheral blood CD3 count must be \> 0.15 x 106 cells/mL within 21 days prior to proceeding with apheresis.
•7. Adequate organ function as defined by:
•1. Absolute neutrophil count (ANC) ≥ 500/μL.
•2. Platelet count ≥ 50,000/μL.
+22 more criteria

Exclusion Criteria

•1. Previous CAR T therapy.
•2. Relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have evidence of MRD after having previously documented MRD-negative remission.
•3. Mixed phenotype acute leukemia or Burkitt's lymphoma
•4. Not in hematological remission at time of enrollment (Remission is defined as \< 5% blasts)
•5. Signs or symptoms of active CNS disease or detectable evidence of CNS disease on MRI at the time of screening. Subjects who have been previously treated for CNS disease but have no evidence of disease at screening are eligible.
•6. History of malignancy unless disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).
•7. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
•8. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \[HBsAg\] positive) or hepatitis C.
•9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.
•10. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.
+16 more criteria

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Key Dates

Start Date

January 24, 2024

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2030

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Lymphoid LeukemiaAcute Lymphoblastic Leukemia

Interventions

CD19 Directed CAR T Cell

DRUG

Contacts

Derek Schatz

CONTACT

17208480628 derek.schatz@cuanschutz.edu

Mathew Angelos, MD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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