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NCT02215967 · ClinicalTrials.gov registry record · Phase 1
Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02215967: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02215967 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02215967, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-08-12 |
| Est. Completion | 2019-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02215967
The ClinicalTrials.gov registry entry for NCT02215967 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02215967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02215967 about?
NCT02215967 is a clinical study titled "Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma". 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 ...
What is the current status of trial NCT02215967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-08-12. Estimated completion is 2019-08-15.
What interventions are being tested in trial NCT02215967?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02215967?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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