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    Tumour-infiltrating lymphocyte (TIL) therapy

    Also known as TIL therapy, tumor-infiltrating lymphocytes, lifileucel, Amtagvi

    Tumour-infiltrating lymphocyte (TIL) therapy takes T cells from a patient's tumour, grows them to large numbers and infuses them back.[1] In February 2024 lifileucel (Amtagvi) became the first FDA-approved tumour-derived T-cell therapy, for advanced melanoma after PD-1 treatment.[2]

    Editor reviewedStrict sourcingUpdated Cancer immunotherapyHealth and medicineLife sciences
    Key facts

    Tumour-infiltrating lymphocyte (TIL) therapy is a form of T-cell transfer therapy that starts from immune cells already inside a patient’s tumour.[3] In 2024 it became the first tumour-derived T-cell therapy approved by the FDA.[2]

    How it works

    Doctors surgically remove part of the tumour, isolate the lymphocytes, identify those that best recognise the cancer, grow them to large numbers in a lab and infuse them back as a single dose.[1] Growing the cells takes 2 to 8 weeks, and patients may receive chemotherapy, and sometimes radiation, to reduce their other immune cells so that the transferred cells work better.[4] The rationale is that these cells have already shown they can recognise the tumour but are too few to control it.[1] Unlike CAR-T, the cells are not given a new engineered receptor.[5]

    The lifileucel approval

    On 16 February 2024 the FDA approved lifileucel (Amtagvi), the first tumour-derived T-cell immunotherapy, for adults with unresectable or metastatic melanoma previously treated with a PD-1 antibody and, if BRAF V600-positive, a BRAF inhibitor.[2] Among 73 patients at the recommended dose, 31.5% responded (3 complete and 20 partial responses).[2] It is approved for use after PD-1 checkpoint inhibitor treatment.[2] NCI notes that lifileucel was originally developed by NCI researchers and was the first cell therapy approved for a solid tumour.[6] Its main serious risk differs from CAR-T’s: TIL therapy can cause capillary leak syndrome, in which fluid leaks out of small blood vessels and blood pressure can fall dangerously.[7]

    How TIL compares with CAR-T

    Both TIL therapy and CAR-T are T-cell transfer therapies.[3] CAR-T starts from blood: T cells are collected, given an engineered chimeric antigen receptor, expanded and infused, over about 3 to 5 weeks.[5] TIL therapy starts from tumour tissue and relies on the cells’ own receptors, selecting the lymphocytes that best recognise the cancer.[1] CAR-T’s approved uses in the US are blood cancers with CD19 or BCMA targets, while lifileucel is approved for a solid tumour, melanoma.[8][2] Durability data at approval were limited: among responders, 43.5% remained in response without progression or death at 12 months.[9]

    Beyond melanoma

    NCI reports promising TIL findings in other cancers, such as cervical squamous cell carcinoma and cholangiocarcinoma.[10]

    A neighbour: engineered TCR therapy

    TIL therapy relies on the T-cell receptors that tumour-infiltrating cells already carry. A related approach gives blood T cells a new, engineered T-cell receptor (TCR) aimed at a chosen tumour antigen. In August 2024 the FDA approved the first such product, Tecelra (afamitresgene autoleucel), for adults with unresectable or metastatic synovial sarcoma who had received chemotherapy, whose tumours express the MAGE-A4 antigen and who carry certain HLA types.[11] Among 44 patients in its pivotal trial, 43.2% responded, with a median response duration of six months.[12] Together with lifileucel and China’s 2026 approval of the claudin-18.2 CAR-T satri-cel for gastric cancer, it shows cell therapies starting to reach solid tumours.[2][13]

    Open questions

    Like CAR-T, TIL therapy requires patient-specific manufacturing, here starting from surgically removed tumour tissue.[1] Researchers describe ex vivo manufacturing of engineered T cells as lengthy and costly, which limits access; that is one motivation for in-vivo-car-t.[14] Whether its benefit extends to other tumour types is being studied.[10]

    Questions readers ask

    How is TIL therapy different from CAR-T?

    Both are T-cell transfer therapies. TIL therapy expands T cells that already sit in the patient's tumour and best recognise it, while CAR-T genetically engineers blood T cells to carry a new receptor.[3][1][5]

    What is TIL therapy approved for?

    Lifileucel is FDA-approved for adults with unresectable or metastatic melanoma previously treated with a PD-1 antibody and, for BRAF V600-positive disease, a BRAF inhibitor.[2]

    How well did lifileucel work in its approval data?

    Among 73 patients at the recommended dose, 31.5% responded.[2]

    Are there other cell therapies for solid tumours?

    Yes. In August 2024 the FDA approved Tecelra (afamitresgene autoleucel), an engineered T-cell receptor therapy for MAGE-A4-positive synovial sarcoma, and in June 2026 China approved the claudin-18.2 CAR-T satri-cel for gastric cancer.[11][13]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      TIL therapy takes lymphocytes from a patient's tumour, selects those that best recognise the cancer, grows them to large numbers and infuses them back. confirmedas of 2026-10-10

    2. [2]

      On 16 February 2024 the FDA approved lifileucel (Amtagvi), the first tumour-derived T-cell therapy, for advanced melanoma after PD-1 treatment; 31.5% of 73 patients at the recommended dose responded. confirmedas of 2024-02-16

    3. [3]

      NCI describes two main types of T-cell transfer therapy: tumour-infiltrating lymphocyte (TIL) therapy and CAR T-cell therapy. confirmedas of 2026-10-10

    4. [4]

      According to NCI, growing a patient's T cells in the lab takes 2 to 8 weeks, during which chemotherapy and sometimes radiation may be used to reduce the patient's other immune cells so the transferred T cells work better. confirmedas of 2024-08-05

    5. [5]

      CAR T-cell therapy collects a patient's T cells, genetically engineers them to make chimeric antigen receptors, grows them to hundreds of millions and returns them as a single infusion, a process NCI puts at about 3 to 5 weeks. confirmedas of 2025-02-26

    6. [6]

      NCI says lifileucel was originally developed by NCI researchers and was the first cell therapy approved for a solid tumour. confirmedas of 2024-08-05

    7. [7]

      NCI says TIL therapy can cause capillary leak syndrome, in which fluid leaks from small blood vessels and causes dangerously low blood pressure that may lead to organ failure and shock. confirmedas of 2024-08-05

    8. [8]

      In April 2024 the FDA required a boxed warning on six approved BCMA- or CD19-directed autologous CAR-T products for the risk of T-cell malignancies, and said patients should be monitored life-long for secondary cancers. confirmedas of 2024-04-18

    9. [9]

      In lifileucel's approval data, 43.5% of patients who responded remained in response without progression or death at 12 months. confirmedas of 2024-02-16

    10. [10]

      NCI notes promising TIL findings in cancers beyond melanoma, such as cervical squamous cell carcinoma and cholangiocarcinoma. confirmedas of 2026-10-10

    11. [11]

      In August 2024 the FDA approved Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma expressing the MAGE-A4 antigen after prior chemotherapy, the first FDA-approved T-cell receptor (TCR) gene therapy. confirmedas of 2024-08-02

    12. [12]

      Among 44 patients treated with Tecelra in its pivotal trial, the overall response rate was 43.2% and the median duration of response was six months. confirmedas of 2024-08-02

    13. [13]

      CARsgen announced on 22 June 2026 that China's NMPA had approved satri-cel that day for Claudin18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines of therapy. confirmedas of 2026-06-22

    14. [14]

      Researchers describe ex vivo manufacturing of engineered T cells as lengthy and costly, limiting access, and current in vivo CAR-T methods as relying on either short-lived expression or random DNA integration. confirmedas of 2026-03-18

    Revision history (2)
    1. Page created.
    2. Refresh: added engineered TCR therapy (Tecelra approval and results) and manufacturing-cost context.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "Tumour-infiltrating lymphocyte (TIL) therapy." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/tumor-infiltrating-lymphocyte-therapy

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