Drugs / Tumor Infiltrating Lymphocytes
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Tumor Infiltrating Lymphocytes

Cell therapy

Developed for
metastatic melanoma · non-small cell lung carcinoma · melanoma · cutaneous melanoma · breast cancer · cancer · cervical carcinoma · colorectal cancer
+48 more · cutaneous neuroendocrine carcinoma · esophageal cancer · gastric cancer · head and neck squamous cell carcinoma · hepatocellular carcinoma · malignant pancreatic neoplasm · squamous cell carcinoma · triple-negative breast carcinoma · uveal melanoma · adult glioblastoma · bladder transitional cell carcinoma · breast carcinoma · central nervous system cancer · cholangiocarcinoma · colon carcinoma · dedifferentiated liposarcoma · digestive system neoplasm · endometrial cancer · Ewing sarcoma · fallopian tube cancer · female reproductive organ cancer · gallbladder cancer · gastric adenocarcinoma · glioblastoma · glioma · head and neck cancer · liver cancer · lung cancer · lymphoid hemopathy · meningioma · mesothelioma · metastatic malignant neoplasm in the brain · mismatch repair cancer syndrome · nasopharyngeal carcinoma · neoplasm · non-invasive bladder urothelial carcinoma · ovarian cancer · ovarian carcinoma · peritoneal carcinoma · primary brain neoplasm · rectal cancer · renal pelvis urothelial carcinoma · rhabdomyosarcoma · sarcoma · skin squamous cell carcinoma · undifferentiated pleomorphic sarcoma · ureter transitional cell carcinoma · urethra transitional cell carcinoma
Investigated by
Iovance Biotherapeutics, Inc. · Shanghai Juncell Therapeutics · Essen Biotech · Shanghai 10th People's Hospital · H. Lee Moffitt Cancer Center and Research Institute · Bristol-Myers Squibb
+36 more · Inge Marie Svane · National Cancer Institute (NCI) · Udai Kammula · Memorial Sloan Kettering Cancer Center · Sun Yat-sen University · Yale University · Abramson Cancer Center at Penn Medicine · Benjamin Gilkey Fund · CAR-T (Shanghai) Cell Biotechnology Co., Ltd. · Cannonball Kids' Cancer Foundation · Eastern Hepatobiliary Surgery Hospital · Fujian Cancer Hospital · Hadassah Medical Organization · Hebei Senlang Biotechnology Inc., Ltd. · Intima Bioscience, Inc. · James Isaacs, MD · Karam Khaddour, MD, MS · Leiden University · Leiden University Medical Center · Masonic Cancer Center, University of Minnesota · Nantes University Hospital · NeogenTC · Richard Wu · Roswell Park Cancer Institute · Saint John's Cancer Institute · Second Affiliated Hospital of Soochow University · Shanghai OriginCell Therapeutics Co., Ltd. · Shanghai Tong Ren Hospital · Sir Run Run Shaw Hospital · Stanford University · Swim Across America · United States Department of Defense · University Health Network, Toronto · University Hospital, Basel, Switzerland · University of Kansas Medical Center · Wake Forest University Health Sciences

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Clinical hold US (FDA) — non-small cell lung carcinoma 2024-03-04

“FDA lifted a partial clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer” iovance.com ↗

Trials 63 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 012 trials
Phase 0 NCT07700121 Oct 2026 → Oct 2028 expected metastatic melanoma Abramson Cancer Center at Penn Medicine Not yet recruiting No outcome recorded
Phase 0 NCT05649618 Dec 2022 → Mar 2024 cancer Fujian Cancer Hospital Unknown No outcome recorded
Phase 0 NCT05333588 Feb 2022 → Feb 2024 adult glioblastoma Hebei Senlang Biotechnology Inc., Ltd. Unknown No outcome recorded
Phase 0 NCT05087745 Dec 2021 → Dec 2024 neoplasm Shanghai Juncell Therapeutics Unknown No outcome recorded
Phase 0 NCT05142475 Nov 2021 → Dec 2026 expected breast cancer Shanghai Juncell Therapeutics Recruiting No outcome recorded
Phase 0 NCT05098197 Sep 2021 → Sep 2026 overdue immunotherapy induced hypophysitis, liver cancer Shanghai Juncell Therapeutics Recruiting No outcome recorded
Phase 0 NCT05098184 Sep 2021 → Sep 2026 overdue melanoma Shanghai Juncell Therapeutics Recruiting No outcome recorded
Phase 0 NCT04960072 Jun 2021 → Dec 2025 overdue digestive system neoplasm Shanghai Juncell Therapeutics Recruiting No outcome recorded
Phase 0 NCT04919616 Jun 2021 → Jun 2023 non-small cell lung carcinoma Shanghai OriginCell Therapeutics Co., Ltd. Unknown No outcome recorded
Phase 0 NCT04943913 May 2021 → Dec 2026 expected glioma Shanghai Juncell Therapeutics Recruiting No outcome recorded
Phase 113 trials
Phase 1 NCT06047977 Jun 2025 → Sep 2029 expected lymphoid hemopathy H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT06190249 Dec 2024 → Jan 2028 melanoma James Isaacs, MD Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT06566092 Mar 2024 → Jul 2026 overdue Ewing sarcoma, central nervous system cancer, melanoma, rhabdomyosarcoma Iovance Biotherapeutics, Inc. Active not recruiting No outcome recorded
Phase 1 NCT06107894 Jan 2024 → Sep 2025 breast cancer, lung cancer NeogenTC Unknown No outcome recorded
Phase 1 NCT05768347 Aug 2023 → Oct 2025 overdue non-invasive bladder urothelial carcinoma H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 1 NCT05681780 Mar 2023 → Jun 2027 expected non-small cell lung carcinoma H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT05640193 Nov 2022 → Nov 2027 expected metastatic melanoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 1 NCT05607095 Nov 2022 → May 2027 expected metastatic melanoma, uveal melanoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT05176470 Jul 2022 → Jul 2023 overdue cutaneous melanoma Richard Wu Active not recruiting No outcome recorded
Phase 1 NCT04766320 Jan 2021 → Dec 2022 female reproductive organ cancer Shanghai 10th People's Hospital Unknown No outcome recorded
Phase 1/212 trials
Phase 1/2 NCT06640582 Oct 2024 → Sep 2026 overdue glioblastoma, meningioma, metastatic malignant neoplasm in the brain, primary brain neoplasm Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT06530303 Sep 2024 → Sep 2026 overdue colon carcinoma, rectal cancer Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT06532799 Sep 2024 → Dec 2025 overdue esophageal cancer, gastric adenocarcinoma Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT06532812 Aug 2024 → Dec 2025 overdue triple-negative breast carcinoma Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT06538012 Aug 2024 → Sep 2026 overdue non-small cell lung carcinoma Essen Biotech Recruiting No outcome recorded
Phase 1/2 NCT04611126 Apr 2021 → Mar 2024 fallopian tube cancer, ovarian cancer, peritoneal carcinoma Inge Marie Svane Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT04538313 Aug 2020 → Oct 2022 hepatocellular carcinoma CAR-T (Shanghai) Cell Biotechnology Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04426669 May 2020 → May 2025 colorectal cancer, esophageal cancer, gallbladder cancer, gastric cancer +1 Intima Bioscience, Inc. Completed No outcome recorded
Phase 1/2 NCT04072263 Aug 2018 → Aug 2021 ovarian carcinoma Leiden University Medical Center Unknown No outcome recorded
Phase 1/2 NCT03638375 Jul 2018 → Nov 2025 drug allergy, poisoning Leiden University Unknown No outcome recorded
Phase 223 trials
Phase 2 NCT07741877 Oct 2026 → Sep 2033 expected dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma Iovance Biotherapeutics, Inc. Recruiting No outcome recorded
Phase 2 NCT07288073 Feb 2026 → Sep 2028 expected cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma Karam Khaddour, MD, MS Recruiting No outcome recorded
Phase 2 NCT07288203 Nov 2025 → Dec 2027 expected cutaneous melanoma Iovance Biotherapeutics, Inc. Active not recruiting No outcome recorded
Phase 2 NCT06455917 Jan 2025 → Dec 2029 expected non-small cell lung carcinoma University Hospital, Basel, Switzerland Recruiting No outcome recorded
Phase 2 NCT06481592 Oct 2024 → May 2028 expected endometrial cancer Iovance Biotherapeutics, Inc. Recruiting No outcome recorded
Phase 2 NCT06151847 Dec 2023 → Jul 2025 cutaneous melanoma, metastatic melanoma University of Kansas Medical Center Completed No outcome recorded
Phase 2 NCT04614103 May 2021 → Dec 2030 expected non-small cell lung carcinoma Iovance Biotherapeutics, Inc. Recruiting No outcome recorded
Phase 2 NCT04111510 Dec 2019 → Jan 2023 triple-negative breast carcinoma Yale University Completed No outcome recorded
Phase 2 NCT03935893 Dec 2019 → Jun 2037 expected colorectal cancer, cutaneous neuroendocrine carcinoma, gastric cancer, malignant pancreatic neoplasm +4 Udai Kammula Active not recruiting No outcome recorded
Phase 2 NCT03935347 Jun 2019 → May 2022 bladder transitional cell carcinoma, renal pelvis urothelial carcinoma, ureter transitional cell carcinoma, urethra transitional cell carcinoma Roswell Park Cancer Institute Withdrawn No outcome recorded Stop: Enrollment
Phase 31 trial
Phase 3 NCT05727904 Mar 2023 → Mar 2028 expected metastatic melanoma Iovance Biotherapeutics, Inc. Recruiting No outcome recorded
Phase not applicable1 trial
— NCT01701674 Oct 2012 → Apr 2016 metastatic melanoma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase not stated1 trial
— NCT05398640 — metastatic melanoma Iovance Biotherapeutics, Inc. Available No outcome recorded
Comparator or background therapy4 trials
Phase 1 NCT03158935 Background Jul 2017 → Aug 2020 melanoma, ovarian carcinoma University Health Network, Toronto Completed No outcome recorded
Phase 1/2 NCT01369888 Background May 2011 → May 2014 metastatic melanoma, skin cancer National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT00006113 Background Jun 1999 → May 2003 cutaneous melanoma University of Southern California Terminated No outcome recorded
Phase 3 NCT06743126 Comparator Jan 2025 → Jan 2028 expected cutaneous melanoma Immatics US, Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 32

DateIssuerRelease
2026-08-06 Iovance Biotherapeutics, Inc. Regulatory Iovance Biotherapeutics Reports Record Second Quarter 2026 Revenue of ~$99M, Business Achievements, and Corporate Updates iovance.com ↗
Fast Track Designation (FTD) Granted by the FDA for Lifileucel in Soft Tissue Sarcomas
2026-06-03 Iovance Biotherapeutics, Inc. Regulatory Iovance’s Amtagvi® (lifileucel) Granted Approval for the Treatment of Advanced Melanoma in Australia iovance.com ↗
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma.
2026-05-07 Iovance Biotherapeutics, Inc. Results Iovance Biotherapeutics Highlights Positive First Quarter 2026 Results, Business Achievements and Corporate Updates iovance.com ↗
Iovance is well positioned through 2026 for long-term revenue growth, while advancing multiple ongoing and new clinical trials, including our registrational trial in advanced sarcomas now underway and encouraging initial data reported today for lifileucel in metastatic serous endometrial cancer.
2026-02-24 Iovance Biotherapeutics, Inc. Regulatory Iovance Biotherapeutics Highlights Strong Fourth Quarter and Full Year 2025 Results, Business Achievements and Corporate Updates iovance.com ↗
U.S. FDA Fast Track Designation Granted for Lifileucel in Second-Line Advanced Non-Small Cell Lung Cancer
2026-02-24 Iovance Biotherapeutics, Inc. Results Iovance Announces Positive Results from the First Clinical Trial for TIL Cell Therapy in Soft Tissue Sarcomas iovance.com ↗
Among the first six evaluable patients treated with lifileucel monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%.
2026-02-05 Iovance Biotherapeutics, Inc. Results Best-in-Class Real-World Data Support Early Amtagvi® Treatment in Advanced Melanoma iovance.com ↗
The physician-assessed confirmed objective response rate (ORR) was 44% (18/41) and the disease control rate was 73% (30/41).
2025-11-06 Iovance Biotherapeutics, Inc. Results Iovance Biotherapeutics Highlights Business Achievements, Pipeline Milestones, and Third Quarter 2025 Results iovance.com ↗
Best-in-Class Clinical Profile for Lifileucel in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) with Median Duration of Response Not Reached after 25+ Months Follow Up
2025-11-03 Iovance Biotherapeutics, Inc. Results Iovance Biotherapeutics Reports Potential Best-in-Class Clinical Data for Lifileucel TIL Cell Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC) iovance.com ↗
The objective response rate (ORR) was 25.6% by RECIST v1.1 following one-time treatment with lifileucel monotherapy in patients with advanced nonsquamous NSCLC.
2025-08-18 Iovance Biotherapeutics, Inc. Regulatory Iovance’s Amtagvi® (lifileucel) Receives Health Canada Approval for Advanced Melanoma iovance.com ↗
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi ® (lifileucel), a tumor-derived autologous T cell immunotherapy.
2025-08-07 Iovance Biotherapeutics, Inc. Results Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2025 iovance.com ↗
The Journal of Clinical Oncology published the final five-year analysis from the Phase 2 C-144-01 clinical trial evaluating one-time lifileucel monotherapy, which represents unprecedented durability and duration of follow-up in previously treated advanced melanoma patients.
2025-07-14 Iovance Biotherapeutics, Inc. Results Real-World Data Demonstrate a 49% Response Rate for Commercial Amtagvi® in Patients with Advanced Melanoma iovance.com ↗
Among 41 evaluable patients treated at four authorized treatment centers, the physician-assessed objective response rate (ORR) was 48.8% (20/41).
2025-06-02 Iovance Biotherapeutics, Inc. Results The Journal of Clinical Oncology Publishes Five-year Analysis of Amtagvi® (lifileucel) in Patients with Advanced Melanoma iovance.com ↗
One-time Amtagvi treatment demonstrated long-term benefit in heavily pretreated patients, including deep and durable responses, meaningful overall survival without further treatment, and no new or late-onset adverse events at a median follow-up of 57.8 months.

All press releases naming this drug 38 releases

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 69 sources stand behind the page.

FieldValueCited text
Known as Tumor Infiltrating Lymphocytes “adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TILs) and high-dose interleukin-2 (IL-2) administered to lymphodepleted patients with melanoma can...” PMID 23650429 ↗ May 2013
25

“Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.” NCT04443296 ↗

“Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion.” NCT04611126 ↗

“Two TIL (Tumor Infiltrating Lymphocytes) injections will be performed: at week 14 and at week 18.” NCT03374839 ↗

“Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells).” NCT00937300 ↗

“Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells).” NCT00937625 ↗

“TILs(Tumor Infiltrating Lymphocytes)” NCT04919616 ↗

“TILs(Tumor Infiltrating Lymphocytes)” NCT06455917 ↗

NCT00604136 ↗

NCT05649618 ↗

NCT00863330 ↗

Show 15 more sources

Known as AMTAGVI “Administration of CD8 PET-guided infusion of lifileucel (AMTAGVI) on Day 0 following completion of the lymphodepleting chemotherapy regimen.” NCT07700121 ↗
Known as lifileucel “tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel” NCT07288073 ↗
13

“Infusion of lifileucel is then given” NCT05398640 ↗

NCT07288203 ↗

NCT06481592 ↗

NCT05607095 ↗

NCT05176470 ↗

NCT05727904 ↗

NCT06151847 ↗

NCT05640193 ↗

NCT07741877 ↗

NCT03645928 ↗

Show 3 more sources

Known as LN-144 “Lifileucel (LN-144/LN-145) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process.” NCT05607095 ↗
2

“Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process.” NCT05640193 ↗

NCT06190249 ↗

Known as LN-144, TIL, autologous tumor-infiltrating lymphocytes “LN-144, TIL, autologous tumor-infiltrating lymphocytes” NCT03645928 ↗
Known as LN-145 “Lifileucel (LN-144/LN-145) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process.” NCT05607095 ↗
8

NCT07288073 ↗

NCT03419559 ↗

NCT03083873 ↗

NCT03645928 ↗

NCT04614103 ↗

NCT04111510 ↗

NCT03935347 ↗

NCT03108495 ↗

Known as LN-145/LN-144 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06566092 ↗
Known as TIL “adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TILs) and high-dose interleukin-2 (IL-2) administered to lymphodepleted patients with melanoma can...” PMID 23650429 ↗ May 2013
8

“Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.” NCT04967833 ↗

“Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue.” NCT01369875 ↗

“treatment with tumour infiltrating lymphocytes (TIL) and interferon-alpha (IFNa).” PMID 33234662 ↗ Nov 2020

“Biological: Tumor Infiltrating Lymphocytes (TIL)” NCT03467516 ↗

“Tumor Infiltrating Lymphocytes (TIL)” NCT04766320 ↗

“Tumor Infiltrating Lymphocytes (TIL)” NCT00863330 ↗

NCT04443296 ↗

NCT03374839 ↗

Known as TILs “Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.” NCT04443296 ↗
7

“Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.” NCT04766320 ↗

“Tumor-infiltrating lymphocytes (TILs) therapy is an advanced form of adoptive cell therapy that harnesses the patient's immune cells to fight cancer.” NCT06532812 ↗

“TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients” NCT05649618 ↗

“autologous TILs, a type of white blood cell that recognizes tumor cells and enters them, thereby causing tumor cells to break down.” NCT03158935 ↗

“Tumor-infiltrating lymphocytes (TILs) therapy is an innovative form of adoptive cell therapy” NCT06538012 ↗

NCT06455917 ↗

NCT04919616 ↗

Known as Tumor infiltrating lymphocyte ClinicalTrials.gov intervention name — accepted as the source's own label NCT04538313 ↗
2

NCT05098197 ↗

NCT05098184 ↗

Known as Tumor Infiltrating Lymphocytes (TIL) “Tumor Infiltrating Lymphocytes (TIL)” NCT01701674 ↗
15

NCT04072263 ↗

NCT04960072 ↗

NCT06532812 ↗

NCT05768347 ↗

NCT06640582 ↗

NCT02375984 ↗

NCT06530303 ↗

NCT04943913 ↗

NCT05333588 ↗

NCT04426669 ↗

Show 5 more sources

Action Deplete “causing tumor cells to break down” NCT03158935 ↗
Modality Cell therapy “therapeutic tumor infiltrating lymphocytes” NCT00006113 ↗
Route Intravenous “Patients receive an IV infusion of the treated cells” NCT00513604 ↗