Clinical Study of the Safety and Efficacy of BCMA CAR-NK
Status:
Recruiting
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to study of the Safety and Efficacy of Chimeric Antigen
Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients with Relapsed/Refractory
Multiple Myeloma
Primary Endpoints:
To evaluate the safety and tolerability of patients with relapsed/refractory multiple myeloma
(RR/MM) after BCMA CAR-NK infusion.
To determine the maximum tolerated dose (MTD) and/or subsequent recommended dose (RD) of BCMA
CAR-NK in patients with RR/MM.
Secondary Endpoints:
To preliminarily evaluate the effectiveness of BCMA CAR-NK in patients with RR/MM.
To preliminarily evaluate the pharmacokinetic parameters of BCMA CAR-NK cells in patients
with RR/MM.
To preliminarily evaluate BCMA CAR-NK cell survival in subjects blood in relation to
efficacy, adverse events and relevant biomarker levels.
To preliminarily evaluate the relationship between donors and subjects KIR-Ligand mismatch
and safety & efficacy.
To preliminarily evaluate the impact of the degree of HLA genotype matching between donors
and subjects on the survival of BCMA CAR-NK cells in the subjects blood.
Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including
pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion and enter
the follow-up period after the end of the DLT observation period.