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NCT03958656 · ClinicalTrials.gov registry record · Phase 1
T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma
A Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03958656: Completed Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, sponsored by National Cancer Institute (NCI).
NCT03958656 is a Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 85-participant average among 7 other Myeloma Multiple trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03958656, a Phase 1 study of Myeloma Multiple and Myeloma, Plasma Cell, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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....
Primary Outcome
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rimiducid
- BIOLOGICAL Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR) T cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2021-01-19 |
| Phase | Phase 1 |
What the finished NCT03958656 record still lists
NCT03958656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 85-participant average among 7 other Myeloma Multiple trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Myeloma Multiple appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03958656 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03958656 about?
NCT03958656 is a clinical study titled "T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma". 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 mu...
What is the current status of trial NCT03958656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-06-13. Estimated completion is 2021-01-19.
What conditions does trial NCT03958656 study?
This clinical trial studies the following conditions: Myeloma Multiple, Myeloma, Plasma Cell.
What interventions are being tested in trial NCT03958656?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rimiducid (DRUG), Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR) T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03958656?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03958656 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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