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Recruiting EARLY_Phase 1 NCT07085559

Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research

Trial Parameters

Condition Multiple Myeloma (MM)
Sponsor Anhui Provincial Hospital
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 36
Sex ALL
Min Age 19 Years
Max Age 75 Years
Start Date 2025-06-23
Completion 2027-06-30
Interventions
Metabolically Armed BCMA CAR-T cells.

Brief Summary

A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.

Eligibility Criteria

Inclusion Criteria: * Age 19 to 75 years old, male or female. The subject or his/her guardian voluntarily signed the informed consent; * Subjects with relapsed or refractory Plasma Cell Neoplasms(including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis)according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment). * Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue. * The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers deter

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