Human BCMA Targeted T Cells Injection Therapy for BCMA-positive Relapsed/Refractory Multiple Myeloma

Study Purpose

To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

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 - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures; 2. 18 to 70 Years Old, Male and female; 3. Expected survival > 12 weeks; 4. Previously diagnosed as multiple myeloma by IMWG updated criteria (2014); 5. Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%; 6. One of the following indicators is satisfied: 1. Serum M protein IgG ≥ 10 g/L, or IgA > 10 mg/L, or IgD > 5 mg/L; 2. Urine M protein ≥ 200 mg/24h; 3. Serum free light chain ≥ 100 mg/L; 7. Patients with relapsed/refractory multiple myeloma. Relapsed is defined as: Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators, and have disease progression within 60 days of the latest treatment ; Refractory is defined as: Patients who achieved remission in the piror therapies, have disease progression within 60 days, or after the latest therapy. 8. Those who relapse 90 days after stem cell transplantation. 9. ECOG score 0-1; 10. Liver, kidney and cardiopulmonary functions meet the following requirements: 1. Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min; 2. Left ventricular ejection fraction >50%; 3. Baseline peripheral oxygen saturation >95%; 4. Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN; 11. The venous access required for collection can be established, and no leukocyte collection contraindications.

Exclusion Criteria:

1. Accompanied by other uncontrolled malignancies; 2. Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis primary screening antibody positive; 3. Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease with poor drug control; 4. Patients who are accounted to be not appropriate for this trail by investigator; 5. Pregnant or lactating, or planning to have a pregnancy during or within 1 year after treatment; 6. Received CAR-T treatment or other gene therapies before enrollment; 7. Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements; 8. Have had severe immediate hypersensitivity reactions to any drugs used in this research; 9. The presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment; 10. In the past two years, the terminal organ was damaged due to autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required; 11. Have a history of central nervous system (CNS) disease, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis.

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.

NCT04003168
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.

Hrain Biotechnology Co., Ltd.
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry, Other
Overall Status Recruiting
Countries China
Conditions

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

Multiple Myeloma
Additional Details

Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.

Arms & Interventions

Arms

Experimental: Human BCMA targeted T Cells Injection

A single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10^6 CAR T +cells/kg. The classic "3+3" dose escalation will be applied.

Interventions

Drug: - Human BCMA targeted T Cells Injection

Autologous genetically modified anti-BCMA CAR transduced T cells

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

Zhengzhou, Henan, China

Status

Recruiting

Address

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan,

Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Changzheng Hospital

Shanghai, Shanghai, 200003

Site Contact

Weijun Fu, Professor

fuweijun2010@hotmail.com

021-81885423

Wenzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000

Site Contact

Kang Yu, Professor

yukang62@126.com

0577-55579486