Status:
UNKNOWN
CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma
Lead Sponsor:
Sichuan University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface rec...
Eligibility Criteria
Inclusion
- Male or female, 18 to 75 years old.
- The expected survival ≥ 12 week
- ECOG ≤ 2
- Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
- The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
- Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
- Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
- Voluntary informed consent is given, agree to follow the trial treatment and visit plan
Exclusion
- Patients with other uncontrollable cancer
- Active hepatitis B, hepatitis C, or HIV infection
- Other uncontrolled active disease
- Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
- Patients with uncontrollable hypertension(≥ grade II)
- Patients with history of uncontrollable mental illness
- Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
- Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
- Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
- Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
- Patients had other conditions that were not appropriate for the study determined by the researchers.
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04727008
Start Date
September 21 2022
End Date
December 31 2025
Last Update
December 12 2023
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041