LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

NCT06888752 | Not Yet Recruiting

• 1 other identifier: LB2403-0001
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

multiple myeloma; Relapsed/Refractory multiple myeloma

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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.

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

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

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

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

• Maximum concentration (Cmax)

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

  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

• Time to Cmax

  The time it takes to reach the maximum concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.

  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

• Time to the last observed concentration

  The time it takes to reach the last observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.

  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

• Area Under the Curve (AUC) of the concentration

  The exposure of CAR positive T cells or transgene CAR copy number in peripheral blood experienced by the subject in a certain time interval.

  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 (10)

• Objective Response Rate (ORR)

  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

• Very Good Partial Response Rate（VGPR）

  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

• Complete response（CR）

  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

• Stringent complete response（sCR）

  : 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

• Minimal residual disease (MRD) negative rate

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

Study Arms (1)

LCAR-M61SQ

EXPERIMENTAL

Each subject will be given a single-dose LCAR-M61SQ cells infusion at each dose level

Biological: Cell injection

Interventions

Cell injection BIOLOGICAL

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.

LCAR-M61SQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Measurable lesions were present;
• Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);
• Expected survival ≥3 months;
• Clinical laboratory values in the screening period meet criteria;

You may not qualify if:

• Received previous therapy targeting GPRC5D targets;
• 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;
• Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
• Serious underlying diseases were present;
• Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
• Also enrolled in other clinical studies.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• Beijing Boren Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Songfu Jiang, MD

CONTACT

15305770033; jiangsongfu@189.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment ，LCAR-61SQ cells intravenous infusion Pretreatment of cyclophosphamide and fludarabine.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share