RecruitingPhase 1NCT05535855

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


Sponsor

University of Colorado, Denver

Enrollment

29 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized immune cell therapy called CAR T-cell therapy (UCD19) for adults with B-cell acute lymphoblastic leukemia (B-ALL) who have achieved remission after chemotherapy but still have trace amounts of leukemia cells detectable by sensitive tests. These remaining cancer cells (called minimal residual disease, or MRD) increase relapse risk, and this therapy aims to eliminate them. **You may be eligible if:** - You are 18 years or older - You have B-cell ALL and are in your first complete remission after chemotherapy - Sensitive tests (flow cytometry or DNA sequencing) show trace cancer cells still remain - Your general health is good enough for the treatment (ECOG score 0–2) - Your heart, liver, and kidney function meet minimum requirements **You may NOT be eligible if:** - You have active leukemia or have not achieved remission - You have a history of certain brain or nervous system diseases - You are currently pregnant or breastfeeding - You have uncontrolled infections or autoimmune diseases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD19 Directed CAR T Cell

The UCD19 CAR T cells are developed through transfection of autologous peripheral blood mononuclear cells with a lentivirus carrying the DNA that encodes a short chain fragment variable region (scFv) derived from an anti-CD19 monoclonal antibody, among other elements.


Locations(1)

University of Colorado Hospital

Aurora, Colorado, United States

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NCT05535855


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