Clinical Trials /

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

NCT03711864

Description:

In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10^5 / kg, 1 x 10^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma
  • Official Title: Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: YMCART201804
  • NCT ID: NCT03711864

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
IM21 CAR-T cellsIM21IM21 CAR-T cells

Purpose

In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10^5 / kg, 1 x 10^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

Detailed Description

      In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was
      performed after screening, blood collection and pretreatment. Starting dose for 5 x 10^5 /
      kg, 1 x 10^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a
      dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases,
      included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3)
      appears in the first 3 patients of a dose group, 3 patients need to be added to the dose
      group (at this time, there are 6 patients in the group). If DLT occurs in 1 of the 3 patients
      (with or without) or 2 of the 6 patients (with or without), no further dose escalation is
      allowed. Researchers and bidders to form drug safety monitoring committee (SRC), every dose
      group of subjects to complete the DLT observation period, after summarizing the security of
      this dose group, determine the test of the next dose, subjects such as draw up the highest
      dose group safety tolerance, SRC to decide whether to continue to increase the dose group of
      research, finally according to have obtained all the safety and efficacy of dose group
      information to determine the recommended dose (RP2D).Dose-limiting toxicity (DLT)
    

Trial Arms

NameTypeDescriptionInterventions
IM21 CAR-T cellsExperimentalIM21 CAR-T cells
  • IM21 CAR-T cells

Eligibility Criteria

        Inclusion Criteria:

          1. The patient had multiple myeloma (according to the updated IMWG diagnostic
             criteria)Active (symptomatic) myeloma

          2. Refractory and recurrent multiple myeloma Refractory definition: 1) treated with at
             least second-line bortezomib or lenalidomide 2) determined by the clinician Definition
             of recurrence: refer to NCCN clinical guidelines for multiple myeloma (2016. V2),
             including recurrence after transplantation.

          3. Age: 18 to 80 years old;

          4. The expected survival time was more than 3 months;

          5. ECoG score 0-2 (refer to Annex 2)

          6. Hemoglobin (HB)≥80g/L; absolute neutrophil count (ANC)>1×10^9/L; platelet
             count(PLT)≥50×10^9/L.

        Those who voluntarily participated in the experiment and signed informed consent.

        Exclusion Criteria:

          1. High risk organ involvement patients: tumor invasion of central nervous system,
             gastrointestinal tract,lung,pericardium,one of the major vessels;

          2. Those who have graft-versus-host reaction and need to use immunosuppressants, or who
             have autoimmune diseases;

          3. Chemotherapy or radiotherapy was used within 3 days before blood collection;

          4. Patients who used systemic steroids within 5 days before blood collection (except
             those who have recently or are currently using inhaled steroids);

          5. The patients who used drugs to stimulate the production of bone marrow hematopoietic
             cells within 5 days before the blood collection period;

          6. Those who have previously used any gene therapy products;

          7. History of epilepsy or other central nervous system diseases;

          8. New York Heart Association (NYHA) grade III or above (refer to Annex 3) (for patients
             with heart disease, this assessment is required);

          9. Creatinine > 1.5 times normal upper limit, ALT / AST>3 times normal upper limit or
             bilirubin >2 times normal upper limit;

         10. Active hepatitis B or hepatitis C virus, HIV or other uncured active infections;

         11. Pregnant or lactating women;

         12. Those who suffer from other uncontrolled diseases are not suitable to join the study;
             Any situation that the researchers believe may increase the risk of subjects or
             interfere with the test results.
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of study related adverse events
Time Frame:2 years
Safety Issue:
Description:defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Peking Union Medical College Hospital

Last Updated

September 30, 2020