RecruitingPhase 1Phase 2NCT04544592

UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL

Phase I/II Dose Escalation and Preliminary Efficacy of CD19 Directed CAR-T Cells Generated Using the Miltenyi CliniMACs Prodigy System (UCD19 CAR-T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) and B-Cell Non-Hodgkin Lymphoma (B-NHL)

Sponsor

University of Colorado, Denver

Enrollment

45 participants

Start Date

Mar 10, 2021

Study Type

INTERVENTIONAL

Conditions

B-cell Non Hodgkin Lymphoma B-cell Acute Lymphoblastic Leukemia

Summary

This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.

Eligibility

Min Age: 31 DaysMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy — where a child's own immune cells are re-engineered to attack cancer cells carrying a protein called CD19 — for children and young adults with B-cell leukemia (B-ALL) or B-cell lymphoma (B-NHL) that has relapsed or is treatment-resistant. **You may be eligible if...** - You (or your child) have a confirmed diagnosis of relapsed or refractory CD19-positive B-ALL or B-NHL - You qualify for leukapheresis (a procedure to collect immune cells from the blood) or already have cells collected - A parent or guardian can provide consent (for patients under 18), with age-appropriate assent from the patient - You are willing to participate in long-term follow-up **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active, uncontrolled infections - You have significant organ dysfunction 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

DRUGCD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells

The CD19 CAR used in this study consists of three main components: the variable regions of the anti-CD19 monoclonal antibody FMC63 71, linked to the TNFRSF-19-derived transmembrane domain, the 4-1BB costimulatory molecule, and the signaling domain of the CD3-zeta molecule. The DNA encoding this receptor was cloned into a lentiviral vector (LV) backbone.