Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Biliary Tract Cancer
Biliary Tract Neoplasms
Cholangiocarcinoma

Type

Interventional

Phase

Phase 2

Design

Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The Phase 2 study will follow the Simon's optimal two-stage design. Fifteen patients will be included in the first stage; if there are 1 or fewer patients responding to therapy the trial will be terminated. If at least 2 responses were observed, expansion into Stage 2 to a total of 47 patients will occur. If at least 6 patients respond to therapy, the study therapy would be considered to have met its primary study goal.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 75 years
Gender: Both males and females

Description

This Phase 2 study will be conducted in conjunction with companion protocol (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) as described below: Cell Preparation: Patients with evaluable locally advanced, recurrent, or metastatic biliary tract cancers who have lesions that can be resected or biopsied with minimum morbidity will undergo resection or biopsy of tumor. Tumor Infiltrating Lymphocytes (TIL) will be obtained while enrolled on the companion protocol Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies. Separate tumor procurement(s) may be performed under the companion protocol to obtain TIL if initial tumor procurement(s) could not successfully generate TIL. The TIL will be grown and expanded for this trial according to standard operating procedures submitted in the IND. The TIL will be assessed for potency by interferon-gamma release. Treatment Phase: Once cells exceed the potency requirement and are projected to exceed the minimum number specified in the COA, the patient will be registered on this study and receive the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of up to 2x1011 lymphocytes (minimum of 1x109 cells) and administration of high-dose intravenous aldesleukin. It is anticipated that TIL that meet the COA will not be achievable in approximately 20% of patients who undergo resection. These patients may undergo a second resection to grow TIL, if another suitable lesion exists. Approximately 6 weeks (+/- 2 weeks) after TIL administration, patients will undergo a complete tumor evaluation and evaluation of toxicity and immunologic parameters. Patients will receive one course of treatment. The start date of the course will be the start date of the chemotherapy; the end date will be the day of the first post-treatment evaluation. Patients may undergo a second treatment. Patients will receive no other experimental agents while on this protocol.

Tracking Information

NCT #: NCT03801083
Collaborators: Not Provided
Investigators: Principal Investigator: Udai S Kammula,, MD UPMC Hillman Cancer Center