Adoptive Cell Therapy Across Cancer Diagnoses
NCT03296137 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-10-26
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Autologous tumor-infiltrating lymphocytes
Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion.
- DRUG
-
One treatment with ipilimumab (3 mg/kg) prior to tumor resection.
- DRUG
-
4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter.
- DRUG
-
proleukin
2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks
- DRUG
-
2 doses (60 mg/kg) prior to TIL infusion
- DRUG
-
Fludara
5 doses (25 mg/m2) prior to TIL infusion
Sponsors & Collaborators
-
Inge Marie Svane
lead OTHER
Principal Investigators
-
Anders H Kverneland, MD · Center for Cancer Immune Therapy, Herlev Hospital
-
Inge Marie Svane, MD, Prof. · Center for Cancer Immune Therapy, Herlev Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-13
- Primary Completion
- 2020-03-13
- Completion
- 2020-07-01
Countries
- Denmark
Study Locations
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