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

Last updated: September 28, 2020
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT03711864
YMCART201804
  • Ages 18-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Refractory and recurrent multiple myeloma Refractory definition: 1) treated with atleast second-line bortezomib or lenalidomide 2) determined by the clinician Definitionof 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; plateletcount(PLT)≥50×10^9/L. Those who voluntarily participated in the experiment and signed informed consent.

Exclusion

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 whohave 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 (exceptthose who have recently or are currently using inhaled steroids);

  5. The patients who used drugs to stimulate the production of bone marrow hematopoieticcells 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 patientswith heart disease, this assessment is required);

  9. Creatinine > 1.5 times normal upper limit, ALT / AST>3 times normal upper limit orbilirubin >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 orinterfere with the test results.

Study Design

Total Participants: 15
Study Start date:
February 25, 2019
Estimated Completion Date:
December 20, 2021

Study 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)

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100005
    China

    Active - Recruiting

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