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Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer

NCT03298763 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-04-28

No results posted yet for this study

Summary

The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC) patients in a Phase I/II clinical trial.

In the phase I study, patients will receive cisplatin and pemetrexed on day one followed by MSCTRAIL cells on day 2. This constitutes one cycle of treatment. Each patient will receive 3 cycles of treatment at 21 day intervals. The aim of phase 1 is to estimate the recommended Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy.

During the phase II study patients will be randomised to either the intervention or the control arm of the study. All patients in both arms will receive cisplatin and pemetrexed on day one of treatment. Patients randomised to the intervention arm will receive the recommended dose of MSCTRAIL from Phase I on day 2 whilst those in the control arm will receive a placebo. As this is a double blind trial both patients and the clinical team will not know whether they are receiving MSCTRAIL or a placebo product. The aim of phase 2 is to assess tolerability and preliminary efficacy of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy.

Conditions

  • Adenocarcinoma of Lung

Interventions

GENETIC

MSCTRAIL

3 doses of MSCTRAIL, administered as an intravenous 60 minutes infusion over 3 cycles, in combination with standard chemotherapy (Cisplatin/Pemetrexed). After 3 cycles patients will have 1-3 further treatment of pemetrexed and cisplatin without MSCTRAIL.

DRUG

Placebo

Placebo will be made up of the same material used to cryopreserve the ATIMP (MSCTRAIL) but will not include the active product

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Sam Janes · UCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2023-09-01
Completion
2025-09-01

Countries

  • United Kingdom

Study Locations

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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 NCT03298763 on ClinicalTrials.gov