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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04537442
Other study ID # Immunochina
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 3, 2020
Est. completion date March 2, 2023

Study information

Verified date August 2020
Source Beijing Immunochina Medical Science & Technology Co., Ltd.
Contact Fei Wu, MD
Phone +8615801390058
Email wufei@immunochina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.


Description:

In this study, about 10 patients with relapsed or refractory multiple myeloma aged ≥60 years were recruited for IM21 CAR-T cell single transfusion therapy. The safety and tolerability of the treatment were evaluated, and the curative effect was initially observed. The research plan includes five stages: screening stage, cell collection stage, chemotherapy pretreatment stage, infusion stage and follow-up stage.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date March 2, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

1. Patients with relapsed or refractory multiple myeloma who had received at least second line regular treatment failure;

2. Age =60 years old;

3. The expected survival time is more than 3 months;

4. ECOG score is 0-2;

5. Those who voluntarily participate in the study and sign the informed consent;

6. Hemoglobin (Hb)=80g/L; Absolute count of neutrophils (ANC) >1×10^9/L Total platelet count (PLT)=35×10^9/L;

7. left ventricular ejection fraction > 45%.

Exclusion Criteria:

1. High-risk viscera-involved patients: the tumor invaded the gastrointestinal tract, lung, pericardium and one of the great vessels;

2. Those who have graft versus host disease and need to use immunosuppressive agents;

3. Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids);

4. Active hepatitis B or C virus, HIV or other untreated active infected persons;

5. Any circumstance that, in the opinion of the investigator, may increase the risk to the subject or interfere with test results;

6. Patients who use chemotherapy or radiotherapy within 3 days before the blood collection stage.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IM21 CAR-T cells
IM21 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days Other Names: Fludarabine Cyclophosphamide

Locations

Country Name City State
China Beijing hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events within 1 month after CAR-T cell infusion The primary endpoint wasIncidence of adverse events within 1 month after CAR-T cell infusion 30days
Secondary Objective Response Rate(ORR) at 90 days 90days
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