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ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)

Multiple Myeloma Clinical Trial

Official title:
The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma

Clinical Trial Summary

This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.

Clinical Trial Description

Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05632380
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital
Contact Yan Xu, M.D., PH.D.
Phone 86-022-23909171
Email xuyan1@ihcams.ac.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date July 14, 2022
Completion date June 30, 2025
View Details
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