A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: C-CAR088

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04295018

0203-007

Details and patient eligibility

About

This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.

Full description

The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
Patients with a clear diagnosis of relapsed or refractory multiple myeloma
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;
At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
ECOG scores 0 - 1;
Good cardiac and pulmonary organ function;
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 criteria

Have a history of allergy to cellular products;
Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;
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;
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;
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.