Status:
UNKNOWN
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
Detailed Description
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
Eligibility Criteria
Inclusion
- Age 18-75 years old, male or female;
- The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
- Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);
- Patients with a clear diagnosis of relapsed or refractory multiple myeloma who have received at least 3 lines of MM (Contains proteasome inhibitors and immunomodulatory therapies that progress or relapse during the most recent treatment or after the end of treatment). Note: The planned treatment plan for one or more cycles is "one-line treatment"; induction chemotherapy, stem cell transplantation, and maintenance treatment (if there is no disease progression between them), it is considered as a one-line treatment plan;
- The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1.0 g/dL(10g/L)
- Urine M protein≥200 mg/24h
- Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
- ECOG scores 0 - 1;
- Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;
- No contraindications of peripheral blood apheresis;
- Expected survival time \> 12 weeks;.
- Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.
Exclusion
- Have a history of allergy to cell ular products;
- Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
- Need to use any anticoagulant (except aspirin);
- Patients requiring urgent treatment due to tumor progression or spinal cord compression;
- Patients with CNS metastasis or symptoms of CNS involvement;
- After allogeneic hematopoietic stem cell transplantation;
- Plasma cell leukemia;
- Received systemic anti-tumor treatment within 2 weeks before apheresis, and within 1 week before apheresis, prednisone (or equivalent amount of other corticosteroids) was applied in excess of 5 mg/d ;
- Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
- Uncontrolled active infection;
- Have used any CAR T cell products or other genetically modified T cell therapy before;
- Live vaccination within 4 weeks before enrollment;
- Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;
- Have a history of alcoholism, drug addiction and mental illness;
- Participated in any other clinical trial within 1 months;
- The investigators believe that there are other circumstances that are not suitable for the trial.
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04322292
Start Date
September 12 2019
End Date
November 1 2021
Last Update
March 26 2020
Active Locations (1)
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1
InstituteHBDH
Tianjin, China, 300000