NCT05190185

A Clinical Trial of TAA06 Injection in Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

B7-H3 (also known as CD276) is widely expressed on the surface of a variety of malignancies solid tumors, while it rarely or even doesn't express on normal tissues. Therefore, B7-H3 is an ideal target for chimeric antigen receptor (CAR) T cells therapy. TAA06 injection is a CAR T injection targeting B7-H3. This is a phase I clinical study with the primary objective of evaluating the safety and tolerability of TAA06 injection in subjects with TAA06-positive advanced solid tumors. The secondary objectives are as follows: to evaluate the distribution, proliferation and persistence of B7-H3-targeted CAR T cells after injection of TAA06 in subjects; to preliminarily evaluate the efficacy of TAA06 injection in subjects with TAA06-positive advanced solid tumor.

Conditions

• Malignant Melanoma, Lung Cancer, or Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TAA06 injection	The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be treated with 1×106\~1×108 CAR-T/kg. And the subjects will be administered once.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-01-13
• Last updated: 2022-01-13

Locations

1 site across 1 country: China