Adoptive Cell Therapy Across Cancer Diagnoses

Sponsor
Inge Marie Svane
Study ID
NCT03296137
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous tumor-infiltrating lymphocytes — BIOLOGICAL
    Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion.
  • Ipilimumab — DRUG
    One treatment with ipilimumab (3 mg/kg) prior to tumor resection.
  • Nivolumab — DRUG
    4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter.
  • proleukin — DRUG
    2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks
  • Cyclophosphamide — DRUG
    2 doses (60 mg/kg) prior to TIL infusion
  • Fludara — DRUG
    5 doses (25 mg/m2) prior to TIL infusion

Study Details

This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.

Key Dates

Start date
Oct 13, 2017
Status verified
Oct 2024
Primary completion
Mar 13, 2020
Completion
Jul 1, 2020

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tumor-infiltrating Lymphocyte (TIL) Therapy with checkpoint inhibitors

Primary Outcome Measure

Number of Participants and Type of Reported Adverse Events [ Time Frame: Up to 2,5 years from begin of study ]

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