Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03602612
PHASE1

T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: Multiple myeloma is a cancer of the blood plasma cells. It usually becomes resistant to standard treatments. Researchers have developed a procedure called gene therapy. It uses a person's own T cells, which are part of the immune system. The cells are changed in a lab and then returned to the person. Researchers hope the changed T cells will be better at recognizing and killing tumor cells. Objective: To test the safety of giving changed T cells to people with multiple myeloma. Eligibility: Adults ages 18-73 who have been diagnosed with multiple myeloma that has not been controlled with standard therapies. Design: Participants will be screened with: Medical history Physical exam Blood tests Heart function tests Bone marrow sample taken by needle in a hip bone. Scan of the chest, abdomen, and pelvis. They may have a brain scan. Pregnancy test Participants will have apheresis. Blood will be removed through an arm vein. The blood will be separated, and T cells removed. The rest of the blood will be returned through a vein in the other arm. Participants will have a central line placed in a large vein in the arm or chest. Participants will get 2 chemotherapy drugs by the central line over 3 days. Two days later, participants will get the changed T cells by the central line. They will stay in the hospital at least 9 days. Participants must stay near the hospital for 2 weeks. Participants will have 8 follow-up visits over the next year for blood and urine tests. They may have scans. Participants blood will be collected regularly over the next several years.

Official title: A Phase I Clinical Trial of T Cells Expressing a Novel Fully-human Anti-BCMA CAR for Treating Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 73 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2018-09-14

Completion Date

2026-04-21

Last Updated

2026-02-25

Healthy Volunteers

No

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) infusion over 30 minutes administered immediately following the cyclophosphamide on day -5, -4, -3

BIOLOGICAL

Anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptors (CARs) T cells

0.75x10\^6 - 12.0X10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States