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Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM

NCT07109323 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-08-07

No results posted yet for this study

Summary

To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.

Conditions

  • Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions
  • Cytogenetics Ultra High Risk
  • Primary Refractory
  • Early Progression
  • Plasma Cell Leukemia
  • Non Paraosseous Extramedullary Infiltration
  • R2-ISS-IV /MPSS-IV

Interventions

DRUG

BCMA CART

Bcma-cart was reinfused at a dose of 1.0-2.0 × 10 \^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion.

Sponsors & Collaborators

  • Hebei Taihe Chunyu Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Dehui Zou · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2028-03-02
Completion
2030-03-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109323 on ClinicalTrials.gov