NCT04427449

4SCAR-CD44v6 T Cell Therapy Targeting Cancer

Status unknown Phase 1, PHASE2 Last updated 11 June 2020

What this trial tests

Phase 1, PHASE2 trial testing CD44v6-specific CAR gene-engineered T cells in Cancers Which Are CD44v6 Positive in 100 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
31 May 2023

31 December 2023

Quick facts

Lead sponsor	Shenzhen Geno-Immune Medical Institute
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 June 2020
Primary completion	31 May 2023
Estimated completion	31 December 2023
Sites	4 locations across China

Drugs / interventions tested

• CD44v6-specific CAR gene-engineered T cells — full drug profile →

Conditions studied

• Cancers Which Are CD44v6 Positive — all drugs for Cancers Which Are CD44v6 Positive →

Sponsor

Shenzhen Geno-Immune Medical Institute

Who can join

Adults 6 Months to 75, any sex, with Cancers Which Are CD44v6 Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers. The study also aims to learn more about the function of the CD44v6 CAR-T cells and their persistency in the patients.

Publications & conference data

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

1. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
2. CAR T-Cell-Based gene therapy for cancers: new perspectives, challenges, and clinical developments.
   Jogalekar MP, Rajendran RL, Khan F, Dmello C, et al · · 2022 · cited 145× · PMID 35936003 · DOI 10.3389/fimmu.2022.925985
3. 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
4. CAR-T Cell Therapy for Breast Cancer: From Basic Research to Clinical Application.
   Yang YH, Liu JW, Lu C, Wei JF. · · 2022 · cited 82× · PMID 35414783 · DOI 10.7150/ijbs.70120
5. Current challenges and therapeutic advances of CAR-T cell therapy for solid tumors.
   Chen T, Wang M, Chen Y, Liu Y. · · 2024 · cited 77× · PMID 38622705 · DOI 10.1186/s12935-024-03315-3
6. Signaling pathways in the regulation of cancer stem cells and associated targeted therapy.
   Manni W, Min W. · · 2022 · cited 52× · PMID 36226253 · DOI 10.1002/mco2.176
7. Tumor buster - where will the CAR-T cell therapy 'missile' go?
   Qu C, Zhang H, Cao H, Tang L, et al · · 2022 · cited 44× · PMID 36261831 · DOI 10.1186/s12943-022-01669-8
8. Facts and Challenges in Immunotherapy for T-Cell Acute Lymphoblastic Leukemia.
   Bayón-Calderón F, Toribio ML, González-García S. · · 2020 · cited 42× · PMID 33081391 · DOI 10.3390/ijms21207685