CART-PSMA Cells for Advanced Prostate Cancer | NCT05656573

NCT05656573

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Chinese PLA General Hospital	OTHER

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The persistence, accumulation, and migration of CART-PSMA cells.	Assessing the trafficking of CART-PSMA cells in the peripheral blood by quantifying the mRNA of CAR gene at the time of each infusion as well as at each time of follow-up blood collection. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.	Up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.