Status:
UNKNOWN
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Relapsed or Refractory 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
- Volunteered to participate in this study and signed informed consent.
- Age 18-75 years old, male or female.
- Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
- Patients with relapsed or refractory multiple myeloma.
- Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
- Serum M protein≥1 g/dl(10g/L)
- Urine M protein≥200 mg/24h
- Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/dl
- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
- At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
- ECOG scores 0 - 1.
- Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
- No contraindications of leukapheresis.
- Expected survival \> 12 weeks.
- Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.
Exclusion
- Have a history of allergy to cellular products.
- Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)\<80g/L, neutrophils\<1000/mm\^3, platelets≦50000/mm\^3 or platelet count maintained by transfusion.
- Subjects with the clinically significant cardiovascular diseases.
- A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
- Use any anticoagulant (except aspirin).
- Patients requiring urgent treatment due to tumor progression or spinal cord compression.
- Patients with active CNS involvement or clinical syndrome of MM meningeal involvement.
- After allogeneic hematopoietic stem cell transplantation.
- Plasma cell leukemia.
- Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
- Uncontrolled active infection.
- Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
- Live vaccine inoculation within four 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 one month.
- The investigators believe that there are other circumstances that are not suitable for the trial.
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03815383
Start Date
April 11 2019
End Date
April 1 2021
Last Update
July 5 2019
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000