RecruitingNot ApplicableNCT06961669

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

An Early Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting CD19 and BCMA in Patients With Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma


Sponsor

Anhui Provincial Hospital

Enrollment

18 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART


Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called ECAR01 — where a patient's own immune cells are genetically engineered to recognize and destroy cancer cells — for people with certain blood cancers that have come back or stopped responding to previous treatments. The cancers include B-cell leukemia, B-cell lymphoma, and multiple myeloma. **You may be eligible if...** - You are over 3 years old - You have relapsed or treatment-resistant B-cell leukemia (B-ALL), B-cell lymphoma (including DLBCL, mantle cell, follicular, or others), or multiple myeloma - Your cancer cells express a protein called CD19 (confirmed by lab test) - You are in reasonably good health (ECOG score 0–2) - You have adequate heart, liver, lung, and kidney function - You are willing to use effective birth control **You may NOT be eligible if...** - You have had a stroke, seizure, dementia, or other significant brain event in the past 6 months - You have another active cancer besides the one being treated - You have a serious heart condition like heart failure or significant arrhythmia - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have an active infection requiring IV antibiotics - You are pregnant or breastfeeding - You have a systemic autoimmune disease or immune deficiency 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

DRUGAnti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis

A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-5.0 x10\^5 CART cells/kg).


Locations(1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

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NCT06961669


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