Not yet recruiting NCT06888752
LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cell injection.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed/Refractory Multiple Myeloma.
Overview
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.
Detailed description
This study is a prospective, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61SQ cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Interventions
- Biological Cell injection
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.
Primary outcome measures
- Dose-limiting toxicity (DLT) rate. [Time frame: 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) [Time frame: 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) [Time frame: through the last subject of DLT exploration completion, about 2years.]
- 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]
- Time to 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]
- Time to the last observed 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]
- 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]
Secondary outcome measures (10)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- Occurrence rate of antidrug antibody [Time frame: From LCAR-M61SQ cells infusion until the date of first documented progression or study completion，assessed about 2 years]
Eligibility criteria
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06888752 · LB2403-0001