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

Peng Liu

Status and phase: Unknown; Phase 1

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma Progression

Treatments: Biological: anti-CD19/BCMA CAR-T cells; Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03706547

SHZS-MM002

Details and patient eligibility

About

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.

Full description

Primary Objectives

1. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.

Secondary Objectives

1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

anti-CD19/BCMA CAR-T cells

Experimental group

Description:

1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide; 2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.

Treatment:

Drug: Cyclophosphamide

Biological: anti-CD19/BCMA CAR-T cells

Drug: Fludarabine