CART-PSMA Cells for Advanced Prostate Cancer

Официальное название

Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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

Первичные конечные точки

• Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation. [Срок оценки: Up to 15 years]

Вторичные конечные точки (8)

• The persistence, accumulation, and migration of CART-PSMA cells. [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to 15 years]
• Progression-free survival (PFS) [Срок оценки: Up to 15 years]
• Patterns of change in PSA (prostate-specific antigen) [Срок оценки: Up to 5 years]
• Serum cytokine profile [Срок оценки: Up to 2 years]
• Phenotypes and frequencies of immune cell subsets in the peripheral blood pre- and post-therapy [Срок оценки: Up to 2 years]
• Changes in circulating tumor cells in peripheral blood [Срок оценки: Up to 2 years]
• Circulating cell-free deoxyribonucleic acid (cfDNA) in peripheral blood [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT05656573 · NT1921-H301-CART-PSMA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗