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

Weijun Fu1 site in 1 country34 target enrollmentOctober 9, 2020

ConditionsRelapsed/Refractory Multiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed/Refractory Multiple Myeloma
Sponsor: Weijun Fu
Enrollment: 34
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

October 9, 2020

End Date

October 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Weijun Fu

Responsible Party

Sponsor Investigator

Principal Investigator

Weijun Fu

Director of Hematology Department

Shanghai Changzheng Hospital

Eligibility Criteria

Inclusion Criteria

•Subject is willing to participate in the clinical study; fully understands and informed the study contents, and signs the informed consent form.
•Chinese subjects ≥ 18 years of age.
•Documented initial diagnosis of MM according to IMWG diagnostic criteria.
•Presence of measurable disease at screening.
•Received a PI and an IMiD (except thalidomide).
•Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
•Expected survival ≥ 3 months.

Exclusion Criteria

•No response to prior BCMA-targeted CAR-T therapy (except for subjects who relapsed after CR to prior CAR-T therapy).
•Prior treatment with any BCMA-targeted monoclonal antibody.
•Diagnosed or previously treated for other invasive malignancies other than multiple myeloma, with the following exceptions:
•Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment; or
•Adequately treated non-melanoma skin cancer without current evidence of disease.
•Prior anti-tumor therapies as follows (prior to conditioning):
•Monoclonal antibody treatment for multiple myeloma within 21 days
•Targeted therapy, epigenetic therapy, or treatment with an investigational product, or used an invasive investigational medical device within 14 days or at least 5 half-lives (whichever is less)
•Cytotoxic therapy within 14 days
•Proteasome inhibitor therapy within 14 days

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Time Frame: Within 30 days after cells infusion

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.