BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
• Collaborators: First Affiliated Hospital of Wenzhou Medical University; Hrain Biotechnology Co., Ltd.; Shanghai Changzheng Hospital
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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

• Clinical performance status of ECOG score 0-4

• 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