Actively Recruiting
Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
Led by Hrain Biotechnology Co., Ltd. · Updated on 2022-12-09
100
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
Sponsors
H
Hrain Biotechnology Co., Ltd.
Lead Sponsor
S
Shanghai Changzheng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
CONDITIONS
Official Title
Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years inclusive
- Willingness to participate and sign informed consent
- Expected survival longer than 12 weeks
- Diagnosed with multiple myeloma by International Myeloma Working Group criteria
- Meeting at least one of the following: serum M protein ≥ 5 g/L; urine M protein ≥ 200 mg/24h; affected serum free light chain ≥ 100 mg/L with abnormal free light chain ratio
- Relapsed or refractory multiple myeloma with at least three prior treatment regimens including a proteasome inhibitor and an immunomodulator
- Disease progression within 12 months of last treatment or less than minimal response or progression within 60 days of last treatment
- ECOG performance status 0 to 2
- Autologous stem cell transplant not possible or relapsed but requiring further treatment
- Adequate liver, kidney, and cardiopulmonary function including creatinine clearance ≥ 40 mL/min, bilirubin ≤ 2x upper limit normal, ALT and AST ≤ 2.5x upper limit normal
- Left ventricular ejection fraction > 50%
- Baseline peripheral oxygen saturation > 95%
- Suitable venous access for leukocyte collection and adequate blood counts (hemoglobin ≥ 70 g/L, platelets ≥ 50×10^9/L, neutrophils ≥ 1.0×10^9/L)
You will not qualify if you...
- History of central nervous system diseases such as seizures, paralysis, stroke, dementia, Parkinson's disease, psychosis, or active CNS involvement by multiple myeloma
- Diagnosis of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Presence of uncontrolled malignancies except certain treated localized cancers
- Active uncontrolled infections including tuberculosis, fungal, bacterial, viral infections requiring systemic intravenous therapy within 14 days prior to enrollment
- Positive for Hepatitis B surface antigen or core antibody with elevated HBV DNA, Hepatitis C antibody with positive RNA, HIV antibody positive, or syphilis positive
- Uncontrolled systemic diseases such as unstable angina, recent stroke or myocardial infarction within 6 months, heart failure (NYHA class ≥ II), uncontrolled diabetes (HbA1c > 8%), severe arrhythmia, or poorly controlled liver, kidney, or metabolic diseases
- History of pacemaker or brain pacemaker implantation
- Prior CAR-T or other genetically modified cell therapies or BCMA-targeting drugs
- Hematopoietic stem cell transplant within 2 months of screening or immunosuppressive therapy for graft-versus-host disease during screening
- Systemic steroid treatment within 14 days before screening or requiring long-term systemic steroids during treatment, except inhalation or topical use
- Received live attenuated vaccine within 4 weeks prior to apheresis
- Terminal organ damage due to autoimmune disease or need for systemic immunosuppressive drugs in past 2 years
- Pregnant or lactating women or men with partners planning pregnancy within 1 year unless using effective contraception
- Inability or unwillingness to comply with study procedures or sign informed consent
- History of severe immediate allergic reactions to study drugs
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
2
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
X
Xuedong Sun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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