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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: Recruiting Phase 2 study of Cholangiocarcinoma and Biliary Tract Cancer, sponsored by Udai Kammula.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest s
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 |
What NCT03801083 shows while recruiting
NCT03801083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT03801083's enrollment target sits among peer trials
59 40th of 60 higher than 21 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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