RecruitingEarly Phase 1NCT06976437

A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors

An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CD19/BCMA CAR-T Cell Treatment for Relapsed/ Refractory B-cell or Plasma Cell-derived Malignant Tumors


Sponsor

YANRU WANG

Enrollment

21 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy — called CAR-T cells — for people with hard-to-treat blood cancers like leukemia, lymphoma, or multiple myeloma that have come back or stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a B-cell blood cancer (such as leukemia, DLBCL, follicular lymphoma, mantle cell lymphoma, or multiple myeloma) - Your cancer has returned or stopped responding to at least one round of standard therapy - Your liver, kidney, and heart function are within acceptable ranges - You are in reasonably good overall health (able to carry out basic daily activities) - At least 2 weeks have passed since your last cancer treatment **You may NOT be eligible if...** - You have active graft-versus-host disease after a previous stem cell transplant - You have a severe active infection or immune deficiency - You have moderate to severe heart failure - You have epilepsy or brain/spinal cord disease - Your lymphoma has spread to the brain, lungs, or gut - You are pregnant or breastfeeding - You have another active cancer (with limited exceptions) 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

DRUGRN1101 injection

RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.


Locations(1)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

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NCT06976437


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