NCT03932565

Interventional Therapy Sequential With the Fourth-generation CAR-T Targeting Nectin4/FAP for Malignant Solid Tumors

Status unknown Phase 1 Last updated 18 November 2020

What this trial tests

Phase 1 trial testing CAR-T therapy for nectin4-positive malignant solid tumor in Nectin4-positive Advanced Malignant Solid Tumor in 30 participants. Status unknown.

Timeline

13 February 2019

Primary endpoint
30 June 2021

31 December 2021

Quick facts

Lead sponsor	The Sixth Affiliated Hospital of Wenzhou Medical University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	13 February 2019
Primary completion	30 June 2021
Estimated completion	31 December 2021
Sites	2 locations across China

Drugs / interventions tested

• CAR-T therapy for nectin4-positive malignant solid tumor — full drug profile →

Conditions studied

• Nectin4-positive Advanced Malignant Solid Tumor — all drugs for Nectin4-positive Advanced Malignant Solid Tumor →

Sponsor

The Sixth Affiliated Hospital of Wenzhou Medical University

Who can join

Adults 18 to 75, any sex, with Nectin4-positive Advanced Malignant Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

According to the high expression of tumor cell-associated antigen Nectin4 in patients with solid tumors such as non-small cell lung cancer, breast cancer, ovarian cancer, bladder cancer, and pancreatic cancer, and in order to target FAP-positive CAFs in the tumor-associated stroma, the Intravenous minimally invasive surgery combined with intratumoral injection of Nectin4/FAP-targeted fourth-generation CAR-T cells (expressing IL7 and CCL19, or IL12) are used to treat Nectin4-positive advanced malignant solid tumors, maximally eliminating residual cancer cells and preventing recurrence.

Publications & conference data

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

1. The tumour microenvironment in pancreatic cancer - clinical challenges and opportunities.
   Ho WJ, Jaffee EM, Zheng L. · · 2020 · cited 963× · PMID 32398706 · DOI 10.1038/s41571-020-0363-5
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. Localized Interleukin-12 for Cancer Immunotherapy.
   Nguyen KG, Vrabel MR, Mantooth SM, Hopkins JJ, et al · · 2020 · cited 318× · PMID 33178203 · DOI 10.3389/fimmu.2020.575597
5. Improving CAR-T immunotherapy: Overcoming the challenges of T cell exhaustion.
   Gumber D, Wang LD. · · 2022 · cited 276× · PMID 35301179 · DOI 10.1016/j.ebiom.2022.103941
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. Identification of Functional Heterogeneity of Carcinoma-Associated Fibroblasts with Distinct IL6-Mediated Therapy Resistance in Pancreatic Cancer.
   McAndrews KM, Chen Y, Darpolor JK, Zheng X, et al · · 2022 · cited 233× · PMID 35348629 · DOI 10.1158/2159-8290.cd-20-1484
8. Cancer-Associated Fibroblasts in Inflammation and Antitumor Immunity.
   Kennel KB, Bozlar M, De Valk AF, Greten FR. · · 2023 · cited 216× · PMID 36399325 · DOI 10.1158/1078-0432.ccr-22-1031