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A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This is a Phase I, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.
Study details:
CLDN6 CAR-T is used as a general term to refer to CLDN6 CAR-T cells from the manual and automated manufacturing processes. The trial consists of two parts. The trial began using a manual CLDN6 CAR-T production process.
Part 1 is a CLDN6 CAR-T dose escalation in lymphodepleted patients until the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CLDN6 CAR-T are defined. Dose escalation with CLDN6 CAR-T cells from the automated manufacturing process follows an accelerated titration design, as opposed to the classical 3+3 trial design used for the dose escalation with CLDN6 CAR-T manufactured with the manual process. In addition, an optional de-escalation dose level may be explored to further evaluate clinical safety and efficacy of CLDN6 CAR-T manufactured with the automated process.
Part 2 is a vaccine-modulated dose escalation using a bifurcated design until the MTD and/or RP2D of CLDN6 CAR-T + CLDN6 RNA-LPX are defined. The trial started with a CLDN6 encoding uridine containing RNA formulated in lipoplexes (CLDN6 uRNA-LPX). In order to optimize CAR-T cell persistence in patients, an alternative RNA-LPX, CLDN6 modRNA-LPX, will be tested once the RP2D dose for CLDN6 CAR-T ± CLDN6 RNA-LPX is identified.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-09-16
Primary completion: 2027-01-01
Study completion finish: 2040-01-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04503278
Intervention or treatment
BIOLOGICAL: CLDN6 CAR-T
BIOLOGICAL: CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
Conditions
- • Solid Tumor
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part 1 - CLDN6 CAR-T
| BIOLOGICAL: CLDN6 CAR-T
|
EXPERIMENTAL: Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
| BIOLOGICAL: CLDN6 CAR-T
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship | Not Specified | up to 25 months |
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs | Not Specified | up to 25 months |
Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period | Not Specified | Day 1 to day 28 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay | Systemic effects in patients will be assessed (e.g., tumor necrosis factor, interferon (IFN)-γ, interleukin (IL)-2, soluble IL-2Rα, interferon-gamma-induced- protein (IP)-10, IL-12, IFN-α, IL-6, soluble IL-6R). | Baseline up to 25 months |
Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors [RECIST 1.1]) is observed as best overall response | Not Specified | up to 25 months |
Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response | Not Specified | up to 25 months |
Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective progressive disease (PD) per RECIST 1.1/recurrence or death from any cause, whichever occurs first | Not Specified | up to 25 months |
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