Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
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ClinicalTrials.gov Identifier: NCT03991741 |
Recruitment Status :
Active, not recruiting
First Posted : June 19, 2019
Last Update Posted : November 3, 2021
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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 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 |

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 |
- Dose Limiting Toxicity [ Time Frame: 2 months ]
- treatment related Adverse Events [ Time Frame: 2 months ]
- Overall Response Rate [ Time Frame: 2 months ]
- Progression Free Survival [ Time Frame: 2 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
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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
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991741
United States, California | |
UC San Diego Moores Cancer Center | |
La Jolla, California, United States, 92093 |
Principal Investigator: | Gregory Daniels, MD, PhD | University of California, San Diego | |
Principal Investigator: | Ezra Cohen, MD | University of California, San Diego |
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 Key Record Dates |
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 |
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 |
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 |