RecruitingPhase 2NCT07106684

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia

A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D/CD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Primary Plasma Cell Leukemia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with primary plasma cell leukemia.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a stem cell transplant (ASCT), CAR-T cell therapy targeting a protein called BCMA, and a maintenance drug (BiTE) targeting another protein called GPRC5D, in newly diagnosed patients with plasma cell leukemia — a rare and aggressive blood cancer. **You may be eligible if:** - You are between 18 and 70 years old - You have newly diagnosed plasma cell leukemia - Your cancer has detectable levels of disease in blood or urine tests - Your cancer cells test positive for BCMA and GPRC5D proteins - Your organs (liver, kidneys) are functioning well enough - You are healthy enough to undergo a stem cell transplant **You may NOT be eligible if:** - You have already received treatment for this condition - Your organ function does not meet study requirements - You are not fit enough for high-dose chemotherapy and transplant 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

PROCEDUREAutologous hematopoietic stem cell transplantation

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.

BIOLOGICALBCMA CAR-T

Patients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT.

DRUGGPRC5D/CD3 BiTEs

Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion and continuing for at least 2 years


Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07106684