CART-BCMA/CS1 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Summary

This phase I trial studies the side effects and how well CART-BCMA/CS1 works in treating patients with multiple myeloma (MM) that has come back (relapsed) or that does not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers, including MM. Immune cells can be engineered to kill MM cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector, that allows them to recognize MM cells.

CART-BCMA cells are such modified T cells that target markers called CS1 or B-cell maturation antigen (BCMA), which is expressed by a type of white blood cell called a "B-cell", which are cells that may help the MM cells grow. These engineered CART-BCMA/CS1 cells may kill MM cells.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Cyclophosphamide

Receive IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Receive IV

OTHER

Fludeoxyglucose F-18

Receive IV

OTHER

Immunotherapy

Receive CART-BCMA/CS1 cells IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Sarah Larson · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-28

Primary Completion

2027-03-28

Completion

2028-03-28

FDA Drug

Yes

Countries

• United States

Study Locations