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RECRUITING
NCT05656573
PHASE1

CART-PSMA Cells for Advanced Prostate Cancer

Sponsor: Nova Therapeutics LLC

View on ClinicalTrials.gov

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

DRUG

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