CART-PSMA Cells for Advanced Prostate Cancer

NCT ID: NCT05656573

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-01

Brief 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.

Detailed Description

Part A (Dose Escalation) + Part B (Expansion Cohort) total up to 20 patients enrolled.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

autologous CART-PSMA cells

Cohort 1： CART-PSMA cells 1-3x10^7/M^2(body surface area) on Day 0; Cohort 2： CART-PSMA cells 1-3x10^8/M^2(body surface area) on Day 0; Cohort 3： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10^7/M^2(body surface area) on Day 0.

Cohort 4： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10^8/M^2(body surface area) on Day 0.

Group Type: EXPERIMENTAL

CART-PSMA cells

Intervention Type: DRUG

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).

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).

Intervention Type: DRUG

Other Intervention Names

No other names

Eligibility Criteria

Inclusion Criteria

1. All participants must have the ability to understand and the willingness to sign a written informed consent.

2. Histologic confirmation of prostate cancer.

3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

5. Under general air conditions, blood oxygen saturation >90%.

6. Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serum bilirubin and alkaline phosphatase < 2 times of ULN.

7. Adequate renal function, specifically serum creatinine < 2.0 mg/dl.

8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.

9. Hemoglobin concentration ≥80g/L.

10. The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.

Exclusion Criteria

1. Patients with other malignant tumors or major diseases.

2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.

3. Patients with uncontrolled active infection.

4. Patients with active hepatitis B or hepatitis C infection.

5. Patients with human immunodeficiency virus (HIV) infection.

6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).

7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease.

8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.

9. Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.

10. Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Nova Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Zhang

Role: STUDY_DIRECTOR

Nova Therapeutics LLC

Locations

Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jay Zhang, MD/PhD

Role: CONTACT

jiezhang8@hotmail.com

858-205-4558

Facility Contacts

Jay Zhang, MD/PhD

Role: primary

Other Identifiers

NT1921-H301-CART-PSMA

Identifier Type: -

Identifier Source: org_study_id