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A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma

NCT04601935 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-11-02

No results posted yet for this study

Summary

This is a prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects with relapsed/refractory multiple myeloma

Conditions

Interventions

BIOLOGICAL

LCAR-BCX cells product

In this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10\^6 cells/kg, 0.5 × 10\^6 cells/kg, 1.0 × 10\^6 cells/kg, 2.0 × 10\^6 cells/kg, and 4.0 × 10\^6 cells/kg, with 0.25 × 10\^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy

Sponsors & Collaborators

  • Nanjing Legend Biotech Co.

    collaborator INDUSTRY

  • Weijun Fu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2023-01-31
Completion
2024-10-31

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 NCT04601935 on ClinicalTrials.gov