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LN-145/LN-144

Phase 1

Soft Tissue Sarcoma | Monoclonal antibody | Oncology |Iovance Biotherapeutics, Inc.|Last Updated: Apr 6, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as LN-145

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

LN-145/LN-144 · 1 trial · 5 indications

Phase 1 1
NCT06566092Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult ParticipantsSoft Tissue Sarcoma
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
Soft Tissue SarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence rate of Treatment-Emergent Adverse Events
Up to 24 months

To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE.

Secondary Endpoints

Objective Response Rate
Up to 24 months
Duration of Response
Up to 24 months
Disease Control Rate
Up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rhabdomyosarcoma (RMS)EXPERIMENTAL -
Ewing Sarcoma (EWS)EXPERIMENTAL -
Primary Central Nervous System TumorEXPERIMENTAL -
MelanomaEXPERIMENTAL -

Interventions

NameTypeDescription
LN-145/LN-144BIOLOGICALA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
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Eligibility Criteria

Age Range6 Months to 21 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent. 2. Histologically or cytologically confirmed recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has fail...

Countries:United States
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Frequently asked questions about LN-145/LN-144

What is LN-145 used for?

LN-145 is an investigational autologous tumor infiltrating lymphocyte therapy being studied for multiple cancers, including soft tissue sarcoma, metastatic non-small cell lung cancer, cutaneous squamous cell carcinoma, and squamous cell carcinoma of the head and neck. It is developed by Iovance Biotherapeutics and is currently in Phase 2 clinical trials.

How does LN-145 work?

LN-145 is a tumor infiltrating lymphocyte therapy, not a monoclonal antibody as sometimes categorized. It uses a patient's own immune cells that have infiltrated their tumor, which are then expanded and infused back to attack the cancer. The therapy targets tumor cells by harnessing the patient's immune system.

Who makes LN-145?

LN-145 is developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IOVA. The company is focused on developing novel cancer immunotherapies based on tumor infiltrating lymphocytes.

What phase is LN-145 in?

LN-145 is in Phase 2 clinical development for several indications. It has received accelerated approval designation from the FDA, but it remains investigational and is not yet fully approved. Clinical trials are ongoing or completed across multiple cancer types.

What clinical trials is LN-145 in?

LN-145 is being studied in several trials, including NCT03083873 for squamous cell carcinoma of the head and neck (completed, Phase 2), NCT04614103 for metastatic non-small cell lung cancer (recruiting, Phase 2), NCT06566092 for pediatric cancers including soft tissue sarcoma (active, Phase 1), and NCT07288073 for cutaneous squamous cell carcinoma (recruiting, Phase 2).

Is LN-145 the same as LN-145/LN-144?

Yes, LN-145 is also known as LN-145/LN-144. This naming convention is used in clinical trial documentation, particularly in the study NCT03083873, which evaluates LN-145/LN-145-S1 autologous tumor infiltrating lymphocytes for the treatment of squamous cell carcinoma of the head and neck.