RecruitingPhase 1Phase 2NCT06101381

CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma

CD19-directed CAR-T Cell Therapy for Refractory or Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma: a Multicenter Phase I/II Trial.

Sponsor

University of Sao Paulo

Enrollment

81 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma, Non-Hodgkin Leukemia, Acute Lymphoblastic

Summary

The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.

Eligibility

Min Age: 3 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-T cell therapy — a cutting-edge treatment where a patient's own immune cells are genetically re-engineered to attack cancer — for people with relapsed or refractory B-cell lymphoma or acute leukemia that targets the CD19 protein on cancer cells. It is intended for patients whose cancer has come back or hasn't responded to prior treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (DLBCL, follicular lymphoma Grade 3B, or similar types) OR acute B-cell leukemia - You have received at least two prior lines of therapy, including treatments with anti-CD20 antibodies - You are either ineligible for or have already completed autologous stem cell transplant - You have measurable disease - You are in good functional health (ECOG less than 2) **You may NOT be eligible if...** - Your cancer has never been treated with standard therapies - You have significant active infections (including HIV, hepatitis B or C) - You have severe heart, lung, liver, or kidney problems - You have had prior allogeneic (donor) stem cell transplant (in some cases) 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

BIOLOGICALCART-19

The academic CART-19 consists of autologous T lymphocytes transduced with a lentiviral vector to express a second-generation chimeric antigen receptor with a single chain variable fragment (scFv) targeting the CD19 antigen conjugated with 4-1BB co-stimulatory and CD3z signaling domains.