LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma

NCT07100067 | Recruiting

• 1 other identifier: LB2502-0001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).

Conditions

Relapsed/Refractory Multiple Myeloma(MM)

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-F33S cell therapy.

  From LCAR-F33S 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-F33S cell infusion

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

  RP2D was 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-F33S

EXPERIMENTAL

Each subject will be given a single-dose LCAR- F33S cells infusion at each dose level.

Biological: LCAR- F33S cells intravenous infusion

Interventions

LCAR- F33S cells intravenous infusion BIOLOGICAL

Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

LCAR-F33S

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 treatment with one PI, one IMiD and a CD38 monoclonal antibody.
• 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 FcRH5 targets.
• Subjects had Plasma cell leukemia, 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

• Institute of Hematology & Blood Diseases Hospital, China: collaborator
• Nanjing Legend Biotech Co.: lead

Study Sites (4)

Beijing Boren Hospital

Beijing, China

NOT YET RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

Wuhan Union Hospital

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Lugui Qiu, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Wang

CONTACT

+86 18618260033; tingting.wang@legendbiotech.cn

Jianling Yao

CONTACT

+86 18610091176; jianling.yao@legendbiotech.cn

Study Design

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

Model Details: Single Group Assignment ，LCAR-F33S cells intravenous infusion Pretreatment of cyclophosphamide and fludarabine.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 3, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): November 20, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)