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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
This product is allogeneic NK cells which are cryopreserved after in vitro CAR genetic modification and scale-up manufacturing. Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGSafety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0
per Adverse Event reporting classified according to CTCAE V5.0
Time frame: Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.