NCT03991741

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

Terminated Phase 1 Results posted Last updated 3 July 2025

What this trial tests

Phase 1 trial testing Autologous Tumor Infiltrating Lymphocytes in Metastatic Melanoma in 3 participants. Terminated before completion.

Timeline

7 October 2020

Primary endpoint
26 January 2023

26 January 2023

Quick facts

Lead sponsor	Gregory Daniels
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	7 October 2020
Primary completion	26 January 2023
Estimated completion	26 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Autologous Tumor Infiltrating Lymphocytes — full drug profile →
• High-Dose Interleukin 2

Conditions studied

• Metastatic Melanoma — all drugs for Metastatic Melanoma →
• Locally Advanced Refractory/Recurrent Melanoma — all drugs for Locally Advanced Refractory/Recurrent Melanoma →
• Metastatic Head and Neck Cancer — all drugs for Metastatic Head and Neck Cancer →
• Locally Advanced Refractory/Recurrent Head and Neck Cancer — all drugs for Locally Advanced Refractory/Recurrent Head and Neck Cancer →

Sponsor

Gregory Daniels — full company profile →

Who can join

18 and older, any sex, with Metastatic Melanoma or Locally Advanced Refractory/Recurrent Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose Limiting Toxicity Primary · 2 months

Dose Limiting Toxicity (DLT)

Group	Value	95% CI
Solid Tumor	1
Solid Tumor	1
Solid Tumor	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Solid Tumor

Serious: 3/3 (100%)

Deaths: 3/3

Serious adverse events (3 terms)

Reaction	System	Solid Tumor
Pericardial effusion	Cardiac disorders	—
Lung infection	Respiratory, thoracic and mediastinal disorders	—
Sepsis	Infections and infestations	—

Other adverse events (47 terms — click to expand)

Reaction	System	Solid Tumor
Febrile neutropenia	Blood and lymphatic system disorders	—
Nausea	Gastrointestinal disorders	—
Fatigue	General disorders	—
Platelet count decreased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Cytokine release syndrome	Immune system disorders	—
Sepsis	Infections and infestations	—
Alanine aminotransferase increased	Investigations	—
Alkaline phosphatase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Blood bilirubin increased	Investigations	—
Neutrophil count decreased	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Pericardial effusion	Cardiac disorders	—
Sinus bradycardia	Cardiac disorders	—
Adrenal insufficiency	Endocrine disorders	—
Abdominal pain	Gastrointestinal disorders	—
Colitis	Gastrointestinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastroesophageal re ux disease	Gastrointestinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Fever	General disorders	—
Localized edema	General disorders	—
Pain	General disorders	—
Bacteremia	Infections and infestations	—
Lung infection	Infections and infestations	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Hypokalemia	Metabolism and nutrition disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Hypophosphatemia	Metabolism and nutrition disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Hallucinations	Psychiatric disorders	—
Acute kidney injury	Renal and urinary disorders	—
Dysuria	Renal and urinary disorders	—

Most-reported serious reactions: Pericardial effusion, Lung infection, Sepsis.

Data from ClinicalTrials.gov NCT03991741 adverse events section.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunomodulatory Effects of IL-2 and IL-15; Implications for Cancer Immunotherapy.
   Yang Y, Lundqvist A. · · 2020 · cited 149× · PMID 33266177 · DOI 10.3390/cancers12123586
2. Adoptive cellular therapy in solid tumor malignancies: review of the literature and challenges ahead.
   Kirtane K, Elmariah H, Chung CH, Abate-Daga D. · · 2021 · cited 146× · PMID 34301811 · DOI 10.1136/jitc-2021-002723
3. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
   Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
4. Adoptive T Cell Therapy for Solid Tumors: Pathway to Personalized Standard of Care.
   Qin SS, Melucci AD, Chacon AC, Prieto PA. · · 2021 · cited 29× · PMID 33916369 · DOI 10.3390/cells10040808
5. Recent clinical researches and technological development in TIL therapy.
   Matsueda S, Chen L, Li H, Yao H, et al · · 2024 · cited 23× · PMID 39264449 · DOI 10.1007/s00262-024-03793-4
6. Therapeutic approaches to enhance natural killer cell cytotoxicity.
   Stenger TD, Miller JS. · · 2024 · cited 14× · PMID 38545115 · DOI 10.3389/fimmu.2024.1356666
7. Trends in immunotherapy for oral squamous cell carcinoma.
   Xue N, Wang Y, Wang Z, Zeng X, et al · · 2025 · cited 7× · PMID 40549116 · DOI 10.1007/s13402-025-01068-3
8. Tumor-Infiltrating Lymphocyte Therapy for the Treatment of Metastatic Melanoma.
   Tsai KK, Komanduri KV. · · 2025 · cited 4× · PMID 40549109 · DOI 10.1007/s40257-025-00957-5