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NCT02830724 · ClinicalTrials.gov registry record · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
- 1
- Study location
NCT02830724: Recruiting Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
NCT02830724 is a Phase 1 study of Breast Cancer and Ovarian Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 124 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02830724, a Phase 1 study of Breast Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.
Primary Outcome
Grade and type of toxicity per dose level; fraction of patients who experience a DLT at a given dose level, and number and grade of each type of DLT
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- BIOLOGICAL Anti-hCD70 CAR transduced PBL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-04-06 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What NCT02830724 shows while recruiting
NCT02830724 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02830724 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02830724 about?
NCT02830724 is a clinical study titled "Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers". Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify th...
What is the current status of trial NCT02830724?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2017-04-06. Estimated completion is 2028-01-01.
What conditions does trial NCT02830724 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Melanoma, Renal Cell Cancer.
What interventions are being tested in trial NCT02830724?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), Anti-hCD70 CAR transduced PBL (BIOLOGICAL).
Who is sponsoring clinical trial NCT02830724?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02830724 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02830724's enrollment target sits among peer trials
124 504th of 1224 higher than 721 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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