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).
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
Interventions
Drug | Synonyms | Arms |
---|
IM21 CAR-T cells | IM21 | IM21 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
Name | Type | Description | Interventions |
---|
IM21 CAR-T cells | Experimental | 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