NCT02959905

Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)

Phase I Clinical Trial of TSA-CTL (Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes) In the Treatment of Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: BGI, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.

Detailed description

This is a single arm, open label and non-randomized clinical study with two parts. In Part 1, 9 subjects with advanced solid tumors will be enrolled into Groups A (no non-myeloablative lymphodepletion), B and C (non-myeloablative lymphodepletion with different chemotherapy intensities) to assess the safety and dose intensity of non-myeloablative lymphodepletion chemotherapy before cell infusion. Depending on results in Part 1, the study may proceed to Part 2, where 15 subjects with advanced solid tumors will be enrolled to receive TSA-CTL cell infusions with or without non-myeloablative lymphodepletion.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TSA-CTL	Patients will receive TSA-CTL iv over 20-30 minutes on day 0.
DRUG	Cyclophosphamide	Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.
DRUG	Fludarabine	Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.
DRUG	Cyclophosphamide	Cyclophosphamide 500 mg/m2/day iv on day -5 and -4 for two days.

Timeline

• Start date: 2016-12-22
• Primary completion: 2020-09-01
• Completion: 2022-05-20
• First posted: 2016-11-09
• Last updated: 2023-02-02

Locations

1 site across 1 country: China