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NCT04160195 · ClinicalTrials.gov registry record · Phase 1
T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04160195: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04160195 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04160195, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: -Cluster of differentiation 19 (CD19) and cluster of differentiation 20 (CD20) are often found on certain cancer cells. Researchers think that a person's T cells can be modified in a lab to kill cells that have CD19 and CD20 on the surface. Objective: -To see if it is safe to give anti-CD19 and anti-CD20 CAR T cells to people with a B cell cancer or Hodgkin lymphoma. Eligibility: -People ages 18 and older with a B cell cancer or Hodgkin lymphoma that has not been controlled with standard therapies Design: * Participants will be screened under protocol 01C0129 with: * Medical history * Physical exam * Blood and heart tests * Bone marrow biopsy: A needle is inserted into the participant's hip bone to remove a small amount of marrow. Scans * Participants will have apheresis: Blood will be removed through a vein. The blood with circulate through a machine that removes the T cells. The rest of the blood will be returned to the participant. * Once a day for 3 days before they get the T cells, participants will receive chemotherapy through a vein. * Participants will receive the T cells through a vein. They will stay in the hospital for at least 9 days. * Participants may have a lumbar puncture: A needle will remove fluid from the spinal cord. * Participants may have a tumor biopsy. * Participants will repeat the screening tests throughout the study. * Participants will have follow-up visits 2 weeks after infusion; monthly for 4 months; at 6, 9, and 12 months; every 6 months for 3 years; and then annually for 5 years. Participants will then be contacted annually for 15 years.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04160195
The ClinicalTrials.gov registry entry for NCT04160195 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 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.
NCT04160195 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04160195 about?
NCT04160195 is a clinical study titled "T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma". Background: -Cluster of differentiation 19 (CD19) and cluster of differentiation 20 (CD20) are often found on certain cancer cells. Researchers think that a person's T cells can be modified in a lab to kill cells that have CD19 and CD20 on the surface. Objective: -To see if it is safe to give ant...
What is the current status of trial NCT04160195?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2019-12-20. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT04160195?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptors (CAR) and Anti-cluster of differentiation 20 (CD20)-CAR T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04160195?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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