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Brief Title: Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urologic Neoplasms
Official Title: A Single-arm, Open-label, Dose-escalation/Expansion, Early-phase Clinical Study of Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urological Neoplasms
Study ID: NCT05990621
Brief Summary: This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-CD70 CAR-T cell injection in patients with CD70-positive Advanced Urologic Neoplasms.
Detailed Description: This study will include two parts, dose escalation phase (accelerated titration and 3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-CD70 CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-CD70 CAR-T cell injection, and establish recommended phase 2 dose (RP2D).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Changhai Hospital, Shanghai, Shanghai, China
Name: Linhui Wang
Affiliation: Changhai Hospital
Role: PRINCIPAL_INVESTIGATOR