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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 18-75 years old, male or female; 2. The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent; 3. Patients with a clear diagnosis of relapsed or refractory multiple myeloma. 4. 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.
5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination; 6. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy. 7. ECOG scores 0
  • - 1; 8.
Good cardiac and pulmonary organ function; 9. Expected survival time > 12 weeks;. 10. 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:

1. Have a history of allergy to cellular products; 2. 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; 3. 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; 4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease; 5. Need to use any anticoagulant (except aspirin); 6. Patients requiring urgent treatment due to tumor progression or spinal cord compression; 7. Patients with CNS metastasis or symptoms of CNS involvement; 8. After allogeneic hematopoietic stem cell transplantation; 9. Plasma cell leukemia; 10. Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents; 11. Uncontrolled active infection; 12. Have used any CAR T cell products or other genetically modified T cell therapy before; 13. 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; 14. Have a history of alcoholism, drug addiction and mental illness; 15. Participated in any other clinical trial within 1 months; 16. The investigators believe that there are other circumstances that are not suitable for the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04295018
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking Union Medical College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daobin Zhou
Principal Investigator Affiliation Peking Union Medical College Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: C-CAR088

Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene

Interventions

Drug: - C-CAR088

Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking Union Medical College Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, Beijing, 100010

Site Contact

Daobin Zhou, PhD&MD

zhoudb@pumch.cn

010-69155020