LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,632
• Neoplasms, Plasma Cell 2,306

Keywords

• multiple myeloma
• Relapsed/Refractory multiple myeloma

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 35 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.

Study arms

• Experimental
  LCAR-M61SQ

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

  Biological: Cell injection

Interventions

• BiologicalCell 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 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

5. 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.

   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

6. 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.

   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

7. 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.

   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

5. Minimal residual disease (MRD) negative rate

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

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

6. Time-to-response（TTR）

   According to International Myeloma Working Group (IMWG) efficacy criteria. TTR is defined as the interval from the date of the first infusion of the LCAR-M61SQ cells 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.

   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

7. Duration of response（DOR）

   According to International Myeloma Working Group (IMWG) efficacy criteria. DOR is 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 .

   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

8. Progression-free survival（PFS）

   According to International Myeloma Working Group (IMWG) efficacy criteria. PFS is defined as the interval from the date of the first infusion of the LCAR-M61SQ cells to the first documentation of disease progression (according to IMWG criteria) or death from any cause, whichever occurred first.

   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

9. Overall survival（OS

   According to International Myeloma Working Group (IMWG) efficacy criteria. Overall survival (OS) is defined as the interval from the date of the first infusion of LCAR-M61SQ cells to death.

   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

10. Occurrence rate of antidrug antibody

    Occurrence rate of LCAR-M61SQ cells preparation ADA.

    Time frame: From LCAR-M61SQ cells infusion until the date of first documented progression or study completion，assessed about 2 years

Individual participant data

Plan to share: No