T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma

Summary

Background:

Multiple myeloma is a blood cancer that is usually incurable. T cells are part of the immune system. Researchers think changing a person's T cells to recognize their cancer could help the person's body kill tumor cells. This is a new approach that uses a patient's own cells to target multiple myeloma.

Objective:

To see if giving anti-Signaling lymphocytic activation molecule F7 (SLAM7) chimeric antigen receptor (CAR) T cells with a stop switch to people with multiple myeloma is safe and to see if adding a gene to stop T-cell activity can limit toxicity of this therapy.

Eligibility:

People ages 18-73 with multiple myeloma for which prior standard treatment has not worked

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood, urine, and heart tests
* Bone marrow samples: A needle inserted into the participant's bone will remove marrow.
* Imaging scans: Participants will lie in a machine that takes pictures of the body.

Participants will have apheresis. They will receive a catheter or central line: A plastic tube will be inserted into a chest or arm vein. Blood will be removed and the T cells separated. The rest of the blood will be returned to the participant. The T cells will be manipulated in the lab.

Participants will get chemotherapy through the central line for 3 days.

Participants will receive the manipulated T cells through the central line. They will stay in the hospital at least 9 days.

Participants will have follow-up visits 2 weeks then 1, 2, 3, 4, 6, 9, and 12 months after the infusion. They will then have visits every 6 months for 3 years. Then they will be contacted once per year for 15 years. All visits will include blood tests, and 3 visits will include bone marrow biopsies....

Conditions

• Myeloma-Multiple
• Myeloma, Plasma-Cell

Interventions

DRUG

Cyclophosphamide

300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3

DRUG

Fludarabine

30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3

DRUG

Rimiducid

0.4 mg/kg of Rimiducid intravenous (IV) over 2 hours. (A maximum of 2 doses separated by at least 48 hours) Note: Rimiducid may be administered as needed based on the patient condition at the discretion of the Principal Investigator.

BIOLOGICAL

Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR) T cells

0.3x10\^6- 12.0x10\^6 CAR+ T cells per kg of recipient bodyweight one-time dose on day 0

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• James N Kochenderfer, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

73 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-13

Primary Completion

2020-10-13

Completion

2021-01-19

FDA Drug

Yes

Countries

• United States

Study Locations