CART-PSMA Cells for Advanced Prostate Cancer

NCT05656573 | Recruiting Phase 1 DMC

• 1 other identifier: NT1921-H301-CART-PSMA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.

  Assessing the type, frequency, severity, and duration of adverse events as a result of CART-PSMA cell infusion via physical, laboratory and imaging examination.

  Up to 15 years

Secondary Outcomes (8)

• The persistence, accumulation, and migration of CART-PSMA cells.

  Up to 2 years

• Overall survival (OS)

  Up to 15 years

• Progression-free survival (PFS)

  Up to 15 years

• Patterns of change in PSA (prostate-specific antigen)

  Up to 5 years

• Serum cytokine profile

  Up to 2 years

Study Arms (1)

autologous CART-PSMA cells

EXPERIMENTAL

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.

Drug: CART-PSMA cells

Interventions

CART-PSMA cells 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).

Also known as: No other names

autologous CART-PSMA cells

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must have the ability to understand and the willingness to sign a written informed consent.
• Histologic confirmation of prostate cancer.
• Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
• Under general air conditions, blood oxygen saturation \>90%.
• 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.
• Adequate renal function, specifically serum creatinine \< 2.0 mg/dl.
• Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
• Hemoglobin concentration ≥80g/L.
• 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.

You may not qualify if:

• Patients with other malignant tumors or major diseases.
• Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
• Patients with uncontrolled active infection.
• Patients with active hepatitis B or hepatitis C infection.
• Patients with human immunodeficiency virus (HIV) infection.
• Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
• Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
• Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
• 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.
• 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.

Sponsors & Collaborators

• Nova Therapeutics LLC: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jay Zhang

  Nova Therapeutics LLC

  STUDY DIRECTOR

Central Study Contacts

Jay Zhang, MD/PhD

CONTACT

858-205-4558; jiezhang8@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 19, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)