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CART-PSMA Cells for Advanced Prostate Cancer
Sponsor: Nova Therapeutics LLC
Summary
This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.
Official title: Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer
Key Details
Gender
MALE
Age Range
35 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-03-01
Completion Date
2025-12-01
Last Updated
2024-11-15
Healthy Volunteers
No
Conditions
Interventions
CART-PSMA cells
This study consists of 2 parts: Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that advanced prostate cancer. Part B (Expansion Cohort): Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation). Up to 4 dosing cohorts, with up to 3 subjects enrolled in each cohort, will be explored as follows: Cohort 1: CART-PSMA cells 1-3x10\^7/M\^2 (body surface area); Cohort 2: CART-PSMA cells 1-3x10\^8/M\^2 (body surface area); Cohort 3: Lymphodepletion chemotherapy + CART-PSMA cells 1-3x10\^7/M\^2 (body surface area); Cohort 4: Lymphodepletion chemotherapy + CART-PSMA cells 1-3x10\^8/M\^2 (body surface area).
Locations (1)
Chinese PLA General Hospital
Beijing, China