Overview

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

Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hrain Biotechnology Co., Ltd.
Collaborators:
First Affiliated Hospital of Wenzhou Medical University
Shanghai Changzheng Hospital
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
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.