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NCT04083495 · ClinicalTrials.gov registry record · Phase 2
CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma
A Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT04083495 is a Phase 2 study of Peripheral T-Cell Lymphoma that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 20 participants, below the 106-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04083495, a Phase 2 study of Peripheral T-Cell Lymphoma, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated. T cells will be genetically modified in a laboratory at UNC-Chapel Hill to enable them to produce CD30 antibody. The modified T cells, called ATLCAR.CD30, will be able to target and attach to lymphoma cancer cells that carry the CD30 antigen. Once they are attached, the hope is that the T cells will attack and destroy the lymphoma cancer cells. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Lymphodepletion will happen over three days prior to ATLCAR.CD30 infusion. If participants respond to this treatment, and there are sufficient unused ATLCAR.CD 30 cells, they may be eligible to receive a second infusion. The second infusion will be given after a second lymphodepletion chemotherapy. Most of the clinic visits in this research will last between 1-8 hours. There are risks associated in participating in this research study. Risks of treatment include infection, fever, nausea, vomiting, neurotoxicity, and cytokine release syndrome which can include low blood pressure or difficulty breathing. Other risks are associated with study procedures, such as biopsies, imaging, infusion, and breach of confidentiality.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
- BIOLOGICAL ATLCAR.CD30 T cells
Study Locations (2)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2038-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083495
The ClinicalTrials.gov registry entry for NCT04083495 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (81% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04083495 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04083495 about?
NCT04083495 is a clinical study titled "CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma". This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated. T cells will be genetically modified in a laboratory at UNC-...
What is the current status of trial NCT04083495?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-09-17. Estimated completion is 2038-08.
What conditions does trial NCT04083495 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.
What interventions are being tested in trial NCT04083495?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), ATLCAR.CD30 T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04083495?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04083495 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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