MedTrace Logo

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma

NCT02215967 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-10-08

Study results available
· View outcomes & findings →

Summary

Background:

\- T cells are white blood cells that fight several cancers. One cancer therapy involves removing a persons' T cells, changing them in a lab, and then returning them to the person. Researchers want to see if this helps people with multiple myeloma.

Objective:

\- To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple myeloma.

Eligibility:

\- Adults ages 18-70 with multiple myeloma that has not responded to standard therapies.

Design:

* Participants may be screened with:
* Medical history
* Physical exam
* Blood and urine tests
* Heart tests
* Bone marrow sample
* Multiple scans and X-rays
* Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.
* The cells will be changed in a laboratory.
* Participants will get 2 chemotherapy drugs over 3 days.
* Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.
* After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.
* Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then every 6 months. A bone marrow sample will be taken at the 2-month visit.
* Participants blood will be collected for several years. Participants will have an annual physical at National Institutes of Health (NIH) for 5 years after the infusion. Then for 10 years they will answer health questionnaires.

Conditions

  • Myeloma, Plasma-Cell
  • Myeloma-Multiple

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

BIOLOGICAL

Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells

0.3x10\^6- 15.0x10\^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

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-12
Primary Completion
2019-04-25
Completion
2019-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215967 on ClinicalTrials.gov