Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer

Sponsor
Essen Biotech
Study ID
NCT06530303
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor Infiltrating Lymphocytes (TIL) — BIOLOGICAL
    Tumor Infiltrating Lymphocytes (TIL) IV
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
  • Fludarabine — DRUG
    Fludarabine will be administered as an intravenous (IV) infusion for five days.
  • Interleukin-2 — DRUG
    After TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.
  • Pembrolizumab — DRUG
    Intravenous (IV) infusion

Study Details

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.

Key Dates

First listed
Jul 31, 2024
Start date
Sep 29, 2024
Status verified
Nov 2024
Primary completion
Sep 10, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy
    Patients receive pembrolizumab IV on day -14, cyclophosphamide IV QD on days -7 to -6, fludarabine IV over 30 minutes QD on days -5 to -1, and TILs IV infusion on day 0. Patients also receive pembrolizumab IV on day 28 and 70, and undergo surgery on day 80. MAINTENANCE: Patients receive pembrolizumab IV every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Adverse Events [ Time Frame: 6 months ]

Central Contacts

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