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NCT Number: NCT06472479

LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma

A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Cancer Hospital, Hefei, Anhui, China

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About this study

This study was a prospective, two-cohort, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61S or LCAR-M61D cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • Received previous therapy targeting GPRC5D and/or CD19 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;
  • 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.

Treatment and study plan

LCAR-M61S cells preparation

Biological

Biological:

LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Other names: Cyclophosphamide, Fludarabine

LCAR-M61D cells preparation

Biological

Biological:

LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Other names: Cyclophosphamide, Fludarabine

Primary outcomes

  1. Dose-limiting toxicity (DLT) rate

    Time frame: From LCAR-M61S and LCAR-M61D cell preparations infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days

    DLT was classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which was considered by the investigator or collaborator to be reasonably related to LCAR-M61S or LCAR-M61D cell therapy.

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

    Time frame: From the date of signing ICF to the date (2 years after LCAR-M61S and LCAR-M61D cell preparation infusion (Day 1)

    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.

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

    Time frame: Through the last subject of DLT exploration completion, about 2 years

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

  4. Maximum concentration (Cmax)

    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

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

  5. Time to Cmax (Tmax)

    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

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

  6. Time to the last observed concentration (Tlast)

    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

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

  7. Area Under the Curve (AUC) of the concentration

    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

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

Secondary outcomes

  1. Objective Response Rate (ORR)

    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

    According to International Myeloma Working Group (IMWG) efficacy criteria.ORR was defined as the proportion of patients with PR or better response after infusion of LCAR-M61S or LCAR-M61D cells.

  2. Very Good Partial Response Rate（VGPR）

    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

    Proportion of subjects achieving VGPR according to IMWG criteria.

  3. Complete response（CR）

    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

    Proportion of subjects achieving CR according to IMWG criteria.

  4. Stringent complete response（sCR）

    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

    Proportion of subjects achieving sCR according to IMWG criteria.

  5. Minimal residual disease (MRD) negative rate

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

    Proportion of subjects achieving minimal residual disease (MRD) negative rate according to IMWG criteria.

  6. Time-to-response（TTR）

    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

    According to International Myeloma Working Group (IMWG) efficacy criteria.TTR was defined as the interval from the date of the first infusion of the LCAR-M61S or LCAR-M61D cells preparation to the date of the first efficacy assessment for which the subject met all criteria for PR or better. Analyses were performed only in responders.

  7. Duration of response（DOR）

    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

    According to International Myeloma Working Group (IMWG) efficacy criteria. DOR was defined as the time from the first documented response (PR or better response) to the first documented evidence of disease progression (as defined according to IMWG criteria) or death from any cause .

  8. Progression-free survival（PFS）

    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

    According to International Myeloma Working Group (IMWG) efficacy criteria.PFS was defined as the interval from the date of the first infusion of the LCAR-M61S or LCAR-M61D cells preparation to the first documentation of disease progression (according to IMWG criteria) or death from any cause, whichever occurred first.

  9. Overall survival（OS）

    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

    According to International Myeloma Working Group (IMWG) efficacy criteria.Overall survival (OS) was defined as the interval from the date of the first infusion of LCAR-M61S or LCAR-M61D cells preparation to death.

  10. Occurrence rate of antidrug antibody

    Time frame: From LCAR-M61S or LCAR-M61D cells preparation infusion until the date of first documented progression or study completion，assessed about 2 years

    Occurrence rate of LCAR-M61S or LCAR-M61D cells preparation ADA

Study contacts

Contact information is provided by the study sponsor or research team.

Lijuan Chen

CONTACT

[email protected]

15850521836

Xuxing Shen

CONTACT

[email protected]

15720803161

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Nanjing Legend Biotech Co.

Registry information

Official study title

A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With Relapsed/Refractory Multiple Myeloma

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 25, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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