BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma

Hrain Biotechnology

Status and phase: Unknown; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Anti-BCMA CAR-T cells; Drug: Immune inhibitors

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03943472

anti-BCMA CART

Details and patient eligibility

About

The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Expected survival > 12 weeks
• Diagnosis of Multiple Myeloma by MWG criteria 20
• Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days
• Important organs function enough to tolerate this therapy
• At least 90 days after stem cell transplantation
• 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
• 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
• Suffering severe cardiovascular or respiratory disease
• Poorly controlled hypertension
• Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
• A history of mental illness and poorly controlled
• Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold)
• Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
• Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
• 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
• Active systemic infections or uncontrolled infection within 14 days prior enrollment
• Subjects suffering disease affects the understanding of informed consent or complying with study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

anti-BCMA CAR-T

Experimental group

Description:

Administration of anti-BCMA CAR-T cells to patients with multiple myeloma

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Anti-BCMA CAR-T cells

anti-BCMA CAR-T+ Immune inhibitors

Experimental group

Description:

Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Anti-BCMA CAR-T cells

Drug: Immune inhibitors