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LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

ConditionRelapsed/Refractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in clinical research;

Age ≥18 years old;

Eastern Cooperative Oncology Group (ECOG) score 0-2;

Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;

Disqualifiers

Received previous therapy targeting GPRC5D targets;

Prior antineoplastic therapy and meet exclusion criteria (before apheresis);

Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.

Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cell injection

    Biological/Vaccine

    LCAR-M61SQ cells intravenous infusion; Prior to infusion of the LCAR-M61SQ cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: LCAR-M61SQExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT) rate.

DLT is classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which is considered by the investigator or collaborator to be reasonably related to LCAR-M61SQ cell therapy.

Time frame
From LCAR-M61SQ cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
2

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

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.

Time frame
From the date of signing ICF to the date (2 years after LCAR-M61SQcell infusion
3

To determine the recommended dose for phase II clinical trials (RP2D)

RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.

Time frame
through the last subject of DLT exploration completion, about 2years.
4

Maximum concentration (Cmax)

The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.

Time frame
From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years

Secondary outcomes

1

Objective Response Rate (ORR)

According to International Myeloma Working Group (IMWG) efficacy criteria. ORR is defined as the proportion of patients with PR or better response after infusion of LCAR-M61SQ cells.

Time frame
From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
2

Very Good Partial Response Rate（VGPR）

Proportion of subjects achieving VGPR according to IMWG criteria.

Time frame
From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
3

Complete response（CR）

Proportion of subjects achieving CR according to IMWG criteria.

Time frame
From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
4

Stringent complete response（sCR）

Proportion of subjects achieving sCR according to IMWG criteria.

Time frame
: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Beijing Boren Hospital

Collaborator

First People's Hospital of Hangzhou

Collaborator

Source ClinicalTrials.gov

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