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

NCT03991741 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 160710
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

melanoma; metastatic; head and neck cancer; solid tumor; adoptive cell therapy; autologous; locally advanced refractory/recurrent melanoma; locally advanced refractory/recurrent head and neck cancer; IL-2

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  Dose Limiting Toxicity (DLT)

  2 months

Study Arms (1)

Solid Tumor

EXPERIMENTAL

Solid Tumor

Biological: Autologous Tumor Infiltrating Lymphocytes; Biological: High-Dose Interleukin 2

Interventions

Autologous Tumor Infiltrating Lymphocytes BIOLOGICAL

Autologous TILs

Solid Tumor

High-Dose Interleukin 2 BIOLOGICAL

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

Solid Tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not candidates for known curative intent therapy.
• Progressed following at least one prior systemic therapy.
• Have advanced melanoma unresectable stage III or stage IV
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gregory Daniels: lead
• Immunotherapy Foundation: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Melanoma; Head and Neck Neoplasms; Neoplasm Metastasis

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Gregory Daniels, MD, PhD
• Organization: University of California, San Diego

CancerCTO@health.ucsd.edu

(858) 822-5354

Study Officials

• Gregory Daniels, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Ezra Cohen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: June 19, 2019
• Study Start: October 7, 2020
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)