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NeoTIL in Advanced Solid Tumors

NCT04643574 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-14

No results posted yet for this study

Summary

Single center, single arm pilot trial to test the feasibility, safety and efficacy of NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or metastatic solid tumors.

The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high dose Interleukin-2 (IL-2) (optional, depending on patient's tolerance).

LDI will be administered once to metastatic lesions using tomotherapy.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

NeoTIL

Adoptive transfer of ex vivo expanded Autologous Tumor-Infiltrating Lymphocytes enriched for tumor antigen specificity (NeoTIL)

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 fourteen doses.

RADIATION

Radiotherapy

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Blanca Navarro-Rodrigo, MD, PhD · Centre Hospitalier Universitaire Vaudois

  • George Coukos, MD, PhD · Centre Hospitalier Universitaire Vaudois

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
2021-03-09
Primary Completion
2027-11-30
Completion
2027-11-30

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 NCT04643574 on ClinicalTrials.gov