BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma

Henan University of Traditional Chinese Medicine

Status and phase

Unknown

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Cyclophosphamide

Drug: Fludarabine

Biological: Anti-BCMA CAR-T cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03093168

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

Primary Objectives

To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
To determine in vivo dynamics and persistency of BCMA CAR-T cells.
To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.

Secondary Objectives

To assess the bone marrow and tumor migration of BCMA CAR-T cells.
To investigate the tumor killing capability of BCMA CAR-T cells in vitro
To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.

Enrollment

10 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 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