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NCT03935893 · ClinicalTrials.gov registry record · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
A Phase 2 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Udai Kammula.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT03935893: Recruiting Phase 2 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Udai Kammula.
NCT03935893 is a Phase 2 study of Colorectal Cancer and Pancreatic Cancer that is actively recruiting participants, run by Udai Kammula. The registered enrollment target is 240 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03935893, a Phase 2 study of Colorectal Cancer and Pancreatic Cancer, is actively recruiting participants, sponsored by Udai Kammula.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).
Primary Outcome
Number of patients with Complete Response (CR) + Number of patients with Partial Response (PR) / total number of patients (# with CR + # with PR + # with SD + # with PD), per RECIST v1.1: CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: ≥ 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkag
Conditions Studied
Interventions
- BIOLOGICAL Tumor Infiltrating Lymphocytes (TIL)
- DRUG Fludarabine + Cyclophosphamide combination
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2038-06-30 |
| Phase | Phase 2 |
What NCT03935893 shows while recruiting
NCT03935893 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (84% lower).
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Tumor Infiltrating Lymphocytes (TIL) is the first listed.
NCT03935893 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03935893 about?
NCT03935893 is a clinical study titled "Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers". This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastr...
What is the current status of trial NCT03935893?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2019-12-03. Estimated completion is 2038-06-30.
What conditions does trial NCT03935893 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Sarcoma, Neuroendocrine Tumors.
What interventions are being tested in trial NCT03935893?
The interventions under investigation include: Tumor Infiltrating Lymphocytes (TIL) (BIOLOGICAL), Fludarabine + Cyclophosphamide combination (DRUG).
Who is sponsoring clinical trial NCT03935893?
This trial is sponsored by Udai Kammula, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03935893 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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Where NCT03935893's enrollment target sits among peer trials
240 132nd of 381 higher than 247 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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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