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

• ClinicalTrials.gov Identifier: NCT03991741
• Recruitment Status: Active, not recruiting
• First Posted: June 19, 2019
• Last Update Posted: November 3, 2021
• Sponsor: Gregory Daniels
• Collaborator: Immunotherapy Foundation
• Information provided by (Responsible Party): Gregory Daniels, University of California, San Diego

Study Description

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. 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).

Condition or disease	Intervention/treatment	Phase
Metastatic Melanoma; Locally Advanced Refractory/Recurrent Melanoma; Metastatic Head and Neck Cancer; Locally Advanced Refractory/Recurrent Head and Neck Cancer	Biological: Autologous Tumor Infiltrating Lymphocytes; Biological: High-Dose Interleukin 2	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
• Actual Study Start Date: October 7, 2020
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: melanoma	Biological: Autologous Tumor Infiltrating Lymphocytes; Autologous TILs; Biological: High-Dose Interleukin 2; 720,000 IU/kg every 8 hours for up to 15 doses
Experimental: head and neck cancer	Biological: Autologous Tumor Infiltrating Lymphocytes; Autologous TILs; Biological: High-Dose Interleukin 2; 720,000 IU/kg every 8 hours for up to 15 doses

Outcome Measures

Primary Outcome Measures :

1. Dose Limiting Toxicity [ Time Frame: 2 months ]

Secondary Outcome Measures :

1. treatment related Adverse Events [ Time Frame: 2 months ]
2. Overall Response Rate [ Time Frame: 2 months ]
3. Progression Free Survival [ Time Frame: 2 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Sponsors and Collaborators

Gregory Daniels

Immunotherapy Foundation

Investigators

• Principal Investigator: Gregory Daniels, MD, PhD; University of California, San Diego
• Principal Investigator: Ezra Cohen, MD; University of California, San Diego

More Information

• Responsible Party: Gregory Daniels, Professor of Medicine, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03991741
• Other Study ID Numbers: 160710
• First Posted: June 19, 2019
• Last Update Posted: November 3, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gregory Daniels, University of California, San Diego:

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

Additional relevant MeSH terms:

Melanoma; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Interleukin-2; Antineoplastic Agents; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs