Clinical trial NCT05656573: CART-PSMA Cells for Advanced Prostate Cancer
Official title: Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Nova Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Chinese PLA General Hospital
First posted: 2022-12-19
Enrollment: 20
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.
timeFrame: Up to 15 years
Secondary outcomes:
measure: The persistence, accumulation, and migration of CART-PSMA cells.
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 15 years
measure: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Patterns of change in PSA (prostate-specific antigen)
timeFrame: Up to 5 years
measure: Serum cytokine profile
timeFrame: Up to 2 years
measure: Phenotypes and frequencies of immune cell subsets in the peripheral blood pre- and post-therapy
timeFrame: Up to 2 years
measure: Changes in circulating tumor cells in peripheral blood
timeFrame: Up to 2 years
measure: Circulating cell-free deoxyribonucleic acid (cfDNA) in peripheral blood
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Nova Therapeutics LLC
name: Jay Zhang
role: STUDY_DIRECTOR
References: