NCT05947487: CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors

Summary

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).

Timeline

Start: 2023-07-15
Primary completion: 2025-12-31
Completion: 2026-12-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CD70-targeting CAR-T cells	Cell therapy	1e+06 cells/kg	—
Subject	CD70-targeting CAR-T cells	Cell therapy	3e+06 cells/kg	—
Subject	CD70-targeting CAR-T cells	Cell therapy	1e+07 cells/kg	—
Background	Albumin-Bound Paclitaxel	Unknown	100 mg/m2	Intravenous
Background	Albumin-Bound Paclitaxel	Unknown	200 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	15 mg/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	30 mg/kg	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous

CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors

Summary

Timeline

Drugs

Indications