RecruitingPhase 1NCT07139509

Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma

Clinical Study on the Safety and Tolerability of Allogeneic, Umbilical Cord Blood-derived, Dual-targeting BCMA/CD19 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma


Sponsor

Xi'an No.3 Hospital

Enrollment

18 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS? Participants will: 1. be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300\~500 mg/m²/d, day -5,-4, and -3). 2. rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment. 3. receive allogeneic cord blood-derived CAR-T cells infusion 4. Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy that targets two proteins at once — BCMA and CD19 — on multiple myeloma cells. CAR-T therapy takes immune cells from the body, engineers them to attack cancer, and infuses them back. This version uses donor cells (allogeneic, from umbilical cord blood) rather than the patient's own cells. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with multiple myeloma that has relapsed (come back) or is refractory (no longer responding to treatment) - You have received multiple prior treatments - Your organ function is adequate to tolerate this therapy **You may NOT be eligible if...** - You have severe organ dysfunction (liver, kidney, heart, or lung problems) - You have an active serious infection - You are pregnant or breastfeeding - You have had a prior allogeneic (donor) stem cell transplant with active graft-versus-host disease 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

DRUGallogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells

dosage form: UCAR-T cell injection Route of Administration: Single intravenous injection Participants will receive lymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) from Day -5 to -3, prior to UCAR-T cell infusion on Day 0.


Locations(1)

Xi'an No.3 Hospital

Xi’an, Shanxi, China

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NCT07139509


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