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NCT03602612 · ClinicalTrials.gov registry record · Phase 1
T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma
A Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03602612: Active Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, sponsored by National Cancer Institute (NCI).
NCT03602612 is a Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 81-participant average among 7 other Myeloma Multiple trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03602612, a Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The MTD is the dose at which a maximum of 1 of 6 patients has a DLT. A DLT is Grade 3 toxicities possibly or probably or definitely related to the Anti-B cell maturation antigen (BCMA) - chimeric antigen receptor (CAR)-expressing T-Cells lasting more than 9 days. Grade 4 toxicities possibly or probably or definitely related to the anti-BCMA CAR T cells. Grade 3 is severe, and Grade 4 is life-threatening.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptors (CARs) T cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2026-04-21 |
| Phase | Phase 1 |
What the registry record for NCT03602612 still lists
NCT03602612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 81-participant average among 7 other Myeloma Multiple trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Myeloma Multiple appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03602612 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03602612 about?
NCT03602612 is a clinical study titled "T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma". 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 ...
What is the current status of trial NCT03602612?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-09-14. Estimated completion is 2026-04-21.
What conditions does trial NCT03602612 study?
This clinical trial studies the following conditions: Myeloma Multiple, Myeloma, Plasma Cell.
What interventions are being tested in trial NCT03602612?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptors (CARs) T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03602612?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03602612 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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