TIL Therapy in cSCC and MCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Karam Khaddour, MD, MS
Study ID
NCT07288073
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LN-145 — BIOLOGICAL
    Autologous tumor-infiltrating lymphocytes via intravenous (into the vein) infusion per protocol
  • Cyclophosphamide — DRUG
    Antineoplastic drug, multi-dose vial, per institutional standards
  • Fludarabine — DRUG
    Nucleotide metabolic inhibitor, single-use vial, via intravenous infusion per institutional standards
  • Interleukin-2 — BIOLOGICAL
    Recombinant, human glycoprotein, single-use vial, via intravenous infusion per protocol

Study Details

The purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy. The names of the study interventions involved in this study are: * Tumor Infiltrating Lymphocytes (a type of cellular therapy) * Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs) * Interleukin-2 (a type of recombinant, human glycoprotein)

Key Dates

Start date
Feb 10, 2026
Status verified
Feb 2026
Primary completion
Sep 29, 2028
Completion
Jun 29, 2029

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: CSCC Autologous TIL Therapy
    10 participants with CSCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TIL infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years
  • Experimental: Cohort B: MCC Autologous TIL Therapy
    4 participants with MCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TILs infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years

Primary Outcome Measure

Tumor-infiltrating lymphocyte (TIL) Production [ Time Frame: TIL infusion will be performed at day 0 of the study. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Karam Khaddour, MD
[email protected]
617-632-6571
Karam Khaddour, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MA

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