NCT03179007

CTLA-4 and PD-1 Antibodies Expressing MUC1-CAR-T Cells for MUC1 Positive Advanced Solid Tumor

Status unknown Phase 1, PHASE2 Last updated 7 June 2017

What this trial tests

Phase 1, PHASE2 trial testing Anti-CTLA-4/PD-1 expressing MUC1-CAR-T in Advanced Solid Tumor in 40 participants. Status unknown.

Timeline

7 June 2017

Primary endpoint
20 January 2019

20 April 2019

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	40
Start date	7 June 2017
Primary completion	20 January 2019
Estimated completion	20 April 2019
Sites	1 location across China

Drugs / interventions tested

• Anti-CTLA-4/PD-1 expressing MUC1-CAR-T — 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 express immune checkpoint antibodies (CTLA-4 and PD-1) and chimeric antigen receptor targeting MUC1 in adult patients with MUC1 positive, advanced recurrent or refractory malignant solid tumors.

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. CAR T cells in solid tumors: challenges and opportunities.
   Marofi F, Motavalli R, Safonov VA, Thangavelu L, et al · · 2021 · cited 394× · PMID 33494834 · DOI 10.1186/s13287-020-02128-1
4. Current Progress in CAR-T Cell Therapy for Solid Tumors.
   Ma S, Li X, Wang X, Cheng L, et al · · 2019 · cited 350× · PMID 31754328 · DOI 10.7150/ijbs.34213
5. Teaching an old dog new tricks: next-generation CAR T cells.
   Tokarew N, Ogonek J, Endres S, von Bergwelt-Baildon M, et al · · 2019 · cited 319× · PMID 30413825 · DOI 10.1038/s41416-018-0325-1
6. 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
7. Glycosylation: mechanisms, biological functions and clinical implications.
   He M, Zhou X, Wang X. · · 2024 · cited 248× · PMID 39098853 · DOI 10.1038/s41392-024-01886-1
8. Chimeric antigen receptor T cell (CAR-T) immunotherapy for solid tumors: lessons learned and strategies for moving forward.
   Li J, Li W, Huang K, Zhang Y, et al · · 2018 · cited 193× · PMID 29433552 · DOI 10.1186/s13045-018-0568-6