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OVSTAR TIL Trial (OVarian Cancer Co-STimulatory Antigen Receptor TIL Trial)

NCT04389229 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-12-16

No results posted yet for this study

Summary

An open label, multi-centre Phase 1/2a study of modified and unmodified autologous Tumour Infiltrating Lymphocytes (TIL) in patients with platinum-resistant ovarian cancer. The purpose of this phase I/II study is to evaluate the feasibility and safety of both standard unmodified TIL (UTIL-01) and TIL engineered to express the co-stimulatory receptor CoStAR (CoTIL-01) in platinum resistant ovarian cancer.

Conditions

  • Ovarian Cancer Metastatic

Interventions

DRUG

cyclophosphamide

600mg/m2/day for 3 days ( on day -5, -4, -3)

DRUG

fludarabine

30mg/m2/day for 3 days ( on day -5, -4, -3)

DRUG

IL-2 (Proleukin)

Subcutaneous injections at a fixed dose of 18 million units once a day following TIL infusion

GENETIC

Unmodified Tumour Infiltrating Lymphocytes (UTIL-01)

Single dose at 5 x 10\^9 - 5 x 10\^10

GENETIC

Gene modified Tumour Infiltrating Lymphocytes (CoTIL-01)

Single dose at 2 x10\^9 (+/- 20%) (engineered TIL)

Sponsors & Collaborators

  • Immetacyte Ltd

    lead INDUSTRY

Principal Investigators

  • Fiona Thistlethwaite, PhD, MRCP · The Christie Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-03-31
Completion
2025-07-31

Countries

  • United Kingdom

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 NCT04389229 on ClinicalTrials.gov