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NCT03801083 · ClinicalTrials.gov registry record · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
A Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, sponsored by Udai Kammula.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT03801083 is a Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer that is actively recruiting participants, run by Udai Kammula. The registered enrollment target is 59 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03801083, a Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, is actively recruiting participants, sponsored by Udai Kammula.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.
Conditions Studied
Interventions
- BIOLOGICAL Tumor Infiltrating Lymphocytes (TIL)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2031-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03801083
The ClinicalTrials.gov registry entry for NCT03801083 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (85% lower). The listed sponsor is Udai Kammula, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Tumor Infiltrating Lymphocytes (TIL) is the first listed.
NCT03801083 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03801083 about?
NCT03801083 is a clinical study titled "Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers". This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic bi...
What is the current status of trial NCT03801083?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2019-02-19. Estimated completion is 2031-01-31.
What conditions does trial NCT03801083 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Biliary Tract Cancer, Biliary Tract Neoplasms.
What interventions are being tested in trial NCT03801083?
The interventions under investigation include: Tumor Infiltrating Lymphocytes (TIL) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03801083?
This trial is sponsored by Udai Kammula, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03801083 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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