MedTrace Logo

Clinical Study of the Safety and Efficacy of BCMA CAR-NK

NCT05652530 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-12-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK)

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.

Sponsors & Collaborators

  • Shenzhen Pregene Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-13
Primary Completion
2023-09-30
Completion
2023-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05652530 on ClinicalTrials.gov