Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peng Liu
• Collaborators: Hrain Biotechnology; Shanghai East Hospital
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Expected survival > 12 weeks

• Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)

• Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma

• Exited measurable lesions and in accordance with one of the following test indicators:

serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy

• The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days

• At least 90 days after stem cell transplantation

• Clinical performance status of ECOG score 0-2

• Creatinine≤2.0 mg/dl

• Bilirubin≤2.0 mg/dl

• The ALT/AST value is lower than 2.5-fold of normal value

• Accessible to intravenous injection, and no white blood cell collection contraindications

• Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom

• 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg:

Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion

• Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

• Patients with symptoms of central nervous system

• Patients with second malignancies in addition to multiple myeloma

• Active hepatitis B or C, HIV infections

• Any other active diseases could affect the enrollment of this trial

• Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment

• Patients with organ failure

• Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy

• A history of mental illness and poorly controlled

• Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

• Patients who are accounted by researchers to be not appropriate for this test

• Subjects suffering disease affects the understanding of informed consent or complying with study protocol