The TIL therapy clinical trial analysis report delivers important insights into ongoing research of 22+ pipeline TIL therapies, clinical strategies, upcoming therapeutics, and commercial analysis.

New York, USA, Aug. 19, 2026 (GLOBE NEWSWIRE) -- TIL Therapy Clinical Trial Pipeline Appears Robust With 17+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The TIL therapy clinical trial analysis report delivers important insights into ongoing research of 22+ pipeline TIL therapies, clinical strategies, upcoming therapeutics, and commercial analysis.

DelveInsight’s 'TIL Therapy Pipeline Insight 2026' report provides comprehensive global coverage of pipeline TIL therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and competitive landscape dynamics, highlighting the strategies of major pharmaceutical companies to advance the pipeline and capitalize on future growth opportunities. In addition, it includes critical insights into clinical trial benchmarking, partnering and licensing activities, and regulatory pathways involving the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies within the TIL therapy domain.

TIL Therapy Clinical Trial Analysis Summary

DelveInsight’s TIL therapy pipeline report depicts a robust space with 17+ active players working to develop 22+ pipeline TIL therapies.
Key TIL therapy companies, such as Iovance Biotherapeutics, Inc., Qingdao Sino-Cell Biomedicine Co., Ltd., Grit Biotechnologies, Shanghai Juncell Therapeutics, CuraCell Holding AB, KSQ Therapeutics, and others, are evaluating new TIL therapies to improve the treatment landscape.
Promising pipeline TIL therapies, such as LN-145, IOV-4001, HS-IT101, GT101, GT307, GC101TIL, CC-38, KSQ-004EX and others, are in different phases of TIL therapy clinical trials.
Approximately 5+ TIL therapies are in the late and mid stages of development.
Key indications for TIL therapies under development include Metastatic NSCLC, Metastatic Cervical cancer, Metastatic Colorectal Cancer, Metastatic Prostate Cancer, Advanced Melanoma (Excluding Uveal Melanoma), Unresectable Melanoma, Glioma, Pancreatic cancer and solid tumors.

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What is TIL Therapy?

Tumor-Infiltrating Lymphocyte (TIL) Therapy is an advanced form of adoptive cell therapy that harnesses a patient's own immune cells to fight cancer. The therapy involves isolating tumor-infiltrating lymphocytes, immune T cells naturally present within a patient's tumor, followed by their ex vivo expansion to generate large numbers of tumor-reactive cells. After a preparative lymphodepleting regimen, the expanded TILs are infused back into the patient, often in combination with interleukin-2 (IL-2) to enhance their survival and activity. TIL therapy is designed to overcome the immunosuppressive tumor microenvironment and boost antitumor immune responses. It has demonstrated significant clinical benefit, particularly in advanced melanoma, and is being investigated across multiple solid tumors, including cervical, lung, head and neck, and gastrointestinal cancers. The recent regulatory approval of TIL-based therapies has marked a major milestone in personalized cancer immunotherapy.

Find out more about TIL therapies @ TIL Therapy Cost

A snapshot of the Pipeline TIL Therapy Drugs mentioned in the report:

Drugs	Company	Phase	Indication	RoA
LN-145	Iovance Biotherapeutics, Inc.	II	Metastatic Non Small Cell Lung Cancer	IV infusion
GT101	GRIT Biotechnology	II	Metastatic Cervical cancer	IV infusion
CC-38	CuraCell Holding AB	II	Metastatic Colorectal Cancer; Metastatic Prostate Cancer	IV infusion
HS-IT101	Qingdao Sino-Cell Biomedicine	II	Advanced Melanoma (Excluding Uveal Melanoma)	IV infusion
KSQ-004EX	KSQ Therapeutics	I/II	Advanced Solid tumors	IV
IOV-4001	Iovance Biotherapeutics	Phase I/II	Unresectable Melanoma; Metastatic Melanoma; Stage III OR Stage IV NSCLC	IV infusion

Learn more about the TIL therapy clinical trials lung cancer cervical cancer solid tumors @ TIL Therapy Clinical Trials

As per Stuti Mahajan, consulting manager at DelveInsight, the tumor-infiltrating lymphocyte (TIL) therapy landscape is rapidly evolving into a key pillar of personalized cancer immunotherapy, driven by a diverse clinical pipeline targeting a wide range of solid tumors. While intravenous infusion remains the predominant route of administration, ongoing innovations such as gene-edited TILs, cytokine-enhanced TIL therapies, combination regimens with immune checkpoint inhibitors, and next-generation cell manufacturing platforms are expanding the therapeutic potential beyond melanoma into indications including non-small cell lung cancer, colorectal, cervical, prostate, breast, pancreatic, head and neck cancers, glioma, and other advanced solid tumors. Recent regulatory and clinical milestones, including investigational approvals, first-patient dosing, and expansion into combination and IL-2-free treatment strategies, underscore the growing maturity of the field and are expected to accelerate clinical development and commercialization. As manufacturing processes become more efficient and clinical evidence continues to strengthen, TIL therapies are anticipated to gain broader adoption, reshape the treatment paradigm for solid tumors, and emerge as a major growth driver within the cell therapy market.

Recent Developments in TIL Therapy Treatment Space

In June 2026, Grit Biotherapeutics announced the clinical trial application (acceptance number: CXSL2600365) of GT101, a tumor-infiltrating lymphocyte (TIL) therapy product independently developed by Beijing Sali Biopharmaceutical Co., Ltd. , in combination with PD-1 monoclonal antibody for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma ("HNSCC"), has been implicitly approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
In June 2026, Iovance Biotherapeutics, Inc. announced an allowance to proceed from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a Phase I/II basket trial of IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy. The Phase I/II trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.
In March 2026, CuraCell TX AB (CuraCell) announced that the first patient has been successfully included into its ongoing Phase I/IIa clinical trial evaluating the company’s novel autologous Tumor-Infiltrating Lymphocyte (TIL) therapy, CC-38, for patients with metastatic colorectal and metastatic prostate cancer. This milestone marks the formal launch of clinical testing for CuraCell’s proprietary TIL therapy, developed using its CytoPLY™ platform. CytoPLY™ enhances the activation and enrichment of tumor-reactive lymphocytes, aiming to generate potent and diverse anti-tumor immune responses.
In December 2025, GT307 injection , a next-generation gene-knockout tumor-infiltrating lymphocyte (TIL) product independently developed by Sapphire Biotech, received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) . This marked another significant milestone for Sapphire Biotech in the field of high-safety gene-edited TILs, following the completion of clinical trial applications for its GT201 product in China and the United States. It also signifies that multiple cell therapy pipelines of the company have entered the clinical stage in the United States.
In April 2025, KSQ Therapeutics, Inc. announced the first patient dosed in the Phase I/II clinical study of KSQ-004EX, a novel CRISPR-engineered Tumor Infiltrating Lymphocyte (eTIL®) therapy. KSQ-004EX consists of eTIL in which the SOCS1 and Regnase-1 genes are inactivated by CRISPR/Cas9 gene editing, giving it the potential to be a best-in-class treatment for a variety of solid tumor indications. KSQ’s CRISPRomics® platform identified SOCS1 and Regnase-1 as key genes inhibiting the ability of TIL to eradicate solid tumors in preclinical models.

Scope of the TIL Therapy Pipeline Report

Coverage: Global
TIL Therapy Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
TIL Therapy Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
TIL Therapy Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
TIL Therapy Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
Key TIL Therapy Companies: Iovance Biotherapeutics, Inc., Qingdao Sino-Cell Biomedicine Co., Ltd., Grit Biotechnologies, Shanghai Juncell Therapeutics, CuraCell Holding AB, KSQ Therapeutics, and others.
Key TIL Therapy Pipeline Therapies: LN-145, IOV-4001, HS-IT101, GT101, GT307, GC101TIL, CC-38, KSQ-004EX and others.

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Table of Contents

1.	TIL Therapy Pipeline Report Introduction
2.	TIL Therapy Pipeline Report Executive Summary
3.	TIL Therapy Pipeline: Overview
4.	Analytical Perspective In-depth Commercial Assessment
5.	TIL Therapy Clinical Trial Therapeutics
6.	TIL Therapy Pipeline: Late-Stage Products (Pre-registration)
7.	TIL Therapy Pipeline: Late-Stage Products (Phase III)
8.	TIL Therapy Pipeline: Mid-Stage Products (Phase II)
9.	TIL Therapy Pipeline: Early-Stage Products (Phase I)
10.	TIL Therapy Pipeline Therapeutics Assessment
11.	Inactive Products in the TIL Therapy Pipeline
12.	Company-University Collaborations (Licensing/Partnering) Analysis
13.	Key Companies
14.	Key Products in the TIL Therapy Pipeline
15.	Unmet Needs
16.	Market Drivers and Barriers
17.	Future Perspectives and Conclusion
18.	Analyst Views
19.	Appendix

For further information on the TIL therapy for metastatic melanoma, reach out @ TIL Therapy Companies

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