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

Metastatic Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991741
• Other study ID #: 160710
• Status: Recruiting
• Phase: Phase 1
• Start date: October 7, 2020
• Est. completion date: August 2026

Study information

• Verified date: December 2022
• Source: University of California, San Diego
• Contact: Gregory Daniels, MD, PhD
• Phone: 858-534-3804
• Email: gdaniels[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Refractory/Recurrent Head and Neck Cancer
• Locally Advanced Refractory/Recurrent Melanoma
• Melanoma
• Metastatic Head and Neck Cancer
• Metastatic Melanoma
• Recurrence

Intervention

Biological:
• Autologous Tumor Infiltrating Lymphocytes
Autologous TILs
• High-Dose Interleukin 2
720,000 IU/kg every 8 hours for up to 15 doses

Locations

Country	Name	City	State
United States	UC San Diego Moores Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Gregory Daniels	Immunotherapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity		2 months
Secondary	treatment related Adverse Events		2 months
Secondary	Overall Response Rate		2 months
Secondary	Progression Free Survival		2 months