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Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

NCT03992326 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-18

No results posted yet for this study

Summary

Single center, single arm phase Ib trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) combined with low-dose irradiation in patients with advanced or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by low dose irradiation (LDI), and then ACT utilizing ex vivo expanded TILs in combination with high dose IL-2 (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.

Conditions

  • Solid Tumor, Adult

Interventions

OTHER

TIL

Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.

DRUG

Fludarabine

Fludarabine will be administered as an intravenous (IV) infusion for five days.

DRUG

Interleukin-2

After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.

OTHER

Radiotherapy

Low-dose irradiation (1Gy) will be administered using tomotherapy to up to 20 measurable tumor lesions once before TIL infusion.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • George Coukos, MD, PhD · Department director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-03-05
Completion
2021-03-05

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992326 on ClinicalTrials.gov