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

  • STATUS
    Recruiting
  • End date
    Jul 11, 2024
  • participants needed
    18
  • sponsor
    Hrain Biotechnology Co., Ltd.
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Updated on 11 March 2021
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Summary

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.

Description

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.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Human BCMA targeted T Cells Injection
Clinical Study IdentifierNCT04003168
SponsorHrain Biotechnology Co., Ltd.
Last Modified on11 March 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures
18 to 70 Years Old, Male and female
Expected survival > 12 weeks
Previously diagnosed as multiple myeloma by IMWG updated criteria (2014)
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%
One of the following indicators is satisfied
Serum M protein IgG 10 g/L, or IgA > 10 mg/L, or IgD > 5 mg/L
Urine M protein 200 mg/24h
Serum free light chain 100 mg/L
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
\. Those who relapse 90 days after stem cell transplantation
\. ECOG score 0-1
\. Liver, kidney and cardiopulmonary functions meet the following
requirements
Creatinine clearance (estimated by Cockcroft Gault formula) 40 mL/min
Left ventricular ejection fraction >50%
Baseline peripheral oxygen saturation >95%
Total bilirubin 2ULN; ALT and AST 2.5 ULN
The venous access required for collection can be established, and no leukocyte collection contraindications

Exclusion Criteria

Accompanied by other uncontrolled malignancies
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
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
Patients who are accounted to be not appropriate for this trail by investigator
Pregnant or lactating, or planning to have a pregnancy during or within 1 year after treatment
Received CAR-T treatment or other gene therapies before enrollment
Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements
Have had severe immediate hypersensitivity reactions to any drugs used in this research
The presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment
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
Have a history of central nervous system (CNS) disease, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis
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