Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

NCT ID: NCT03991741

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2023-01-26

Brief Summary

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells.

Detailed Description

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).

Conditions

Metastatic Melanoma; Locally Advanced Refractory/Recurrent Melanoma; Metastatic Head and Neck Cancer; Locally Advanced Refractory/Recurrent Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solid Tumor

Solid Tumor

Group Type: EXPERIMENTAL

Autologous Tumor Infiltrating Lymphocytes

Intervention Type: BIOLOGICAL

Autologous TILs

High-Dose Interleukin 2

Intervention Type: BIOLOGICAL

720,000 IU/kg every 8 hours for up to 15 doses

Interventions

Autologous Tumor Infiltrating Lymphocytes

Autologous TILs

Intervention Type: BIOLOGICAL

High-Dose Interleukin 2

720,000 IU/kg every 8 hours for up to 15 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
• Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:

1. Not candidates for known curative intent therapy.

2. Progressed following at least one prior systemic therapy.

3. Have advanced melanoma unresectable stage III or stage IV

4. Have advanced head and neck recurrent or metastatic disease

• Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
• Life expectancy of greater than 3 months.
• ECOG Performance Status of 0 or 1.
• Adequate organ and marrow function
• Seronegative for HIV antibody.
• Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
• More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
• Patient has stable or progressing disease after at least one prior treatment.
• Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Exclusion Criteria

• Currently using investigational agents.
• Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
• Patient is a female of child-bearing potential who is pregnant or breastfeeding
• Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
• Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
• Patient has opportunistic infections.
• Patient has a history of coronary revascularization or ischemic symptoms.
• Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunotherapy Foundation

UNKNOWN

Sponsor Role: collaborator

Gregory Daniels

OTHER

Sponsor Role: lead

Responsible Party

Gregory Daniels

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gregory Daniels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Ezra Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UC San Diego Moores Cancer Center

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

160710

Identifier Type: -

Identifier Source: org_study_id