NCT03615313: PAEMCMPAST

PD-1 Antibody Expressing mesoCAR-T Cells for Mesothelin Positive Advanced Solid Tumor

Status unknown Phase 1, PHASE2 Last updated 3 August 2018

What this trial tests

Phase 1, PHASE2 trial testing PD-1 antibody expressing mesoCAR-T cells in Advanced Solid Tumor in 50 participants. Status unknown.

Timeline

6 August 2018

Primary endpoint
3 August 2020

3 December 2020

Quick facts

Lead sponsor	Shanghai Cell Therapy Research Institute
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	6 August 2018
Primary completion	3 August 2020
Estimated completion	3 December 2020
Sites	1 location across China

Drugs / interventions tested

• PD-1 antibody expressing mesoCAR-T cells — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Shanghai Cell Therapy Research Institute

Who can join

Adults 18 to 80, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-label, one center clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to target mesothelin and express PD-1 antibodies in adult patients with advanced recurrent or refractory malignant solid tumors, which were positive expression of mesothelin.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CAR T Cells for Solid Tumors: New Strategies for Finding, Infiltrating, and Surviving in the Tumor Microenvironment.
   Martinez M, Moon EK. · · 2019 · cited 653× · PMID 30804938 · DOI 10.3389/fimmu.2019.00128
2. CAR-cell therapy in the era of solid tumor treatment: current challenges and emerging therapeutic advances.
   Maalej KM, Merhi M, Inchakalody VP, Mestiri S, et al · · 2023 · cited 421× · PMID 36717905 · DOI 10.1186/s12943-023-01723-z
3. Recent advances in CAR-T cell engineering.
   Huang R, Li X, He Y, Zhu W, et al · · 2020 · cited 274× · PMID 32616000 · DOI 10.1186/s13045-020-00910-5
4. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
5. Genetically engineered T cells for cancer immunotherapy.
   Li D, Li X, Zhou WL, Huang Y, et al · · 2019 · cited 168× · PMID 31637014 · DOI 10.1038/s41392-019-0070-9
6. Current advances and challenges in CAR T-Cell therapy for solid tumors: tumor-associated antigens and the tumor microenvironment.
   Yan T, Zhu L, Chen J. · · 2023 · cited 132× · PMID 36707873 · DOI 10.1186/s40164-023-00373-7
7. Mesothelin as a biomarker for targeted therapy.
   Lv J, Li P, Li P. · · 2019 · cited 101× · PMID 31463062 · DOI 10.1186/s40364-019-0169-8
8. Arming CAR-T cells with cytokines and more: Innovations in the fourth-generation CAR-T development.
   Tang L, Pan S, Wei X, Xu X, et al · · 2023 · cited 100× · PMID 37803832 · DOI 10.1016/j.ymthe.2023.09.021