PSMA-specific CAR-T Cell Therapy

NCT04429451 | Unknown Phase 1

• 1 other identifier: GIMI-IRB-20003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of PSMA-specific CAR-T cell therapy in patients with PSMA positive tumor. Another goal of the study is to learn more about the function of the PSMA CAR-T cells and their persistency in the patients.

Conditions

PSMA Positive Tumors or Tumor Tissues

Keywords

chimeric antigen receptor; adoptive T cell transfer; PSMA; Prostate cancer; Tumor microenvironment; CAR

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events.

  Determine the toxicity profile the 4SCAR-PSMA cells with Common Toxicity Criteria for Adverse Effects version 4.0

  3 year

Secondary Outcomes (3)

• Anti-tumor effects

  1 year

• The expansion and persistence of 4SCAR-PSMA T cells

  1 year

• Survival time of the patients

  3 year

Study Arms (1)

4SCAR-PSMA Cell Therapy for PSMA positive tumor

EXPERIMENTAL

Infusion of 4SCAR-PSMA T cells at 10\^6 cells/kg body weight via IV

Biological: 4SCAR-PSMA T cells

Interventions

4SCAR-PSMA T cells BIOLOGICAL

Infusion of 4SCAR-PSMA T cells at 10\^6 cells/kg body weight via IV

4SCAR-PSMA Cell Therapy for PSMA positive tumor

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent.
• The expression status of PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
• Body weight greater than or equal to 10 kg.
• Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
• Life expectancy: at least 8 weeks.
• Prior Therapy:
• There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less.
• Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.
• At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen.
• At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.
• At least 1 week since any radiation therapy at the time of study entry.
• Karnofsky/jansky score of 60% or greater.
• Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent.
• Pulse Ox greater than or equal to 90% on room air.
• Liver function: defined as alanine transaminase (ALT) \<3x upper limit of normal (ULN), aspartate aminotransferase (AST) \<3x ULN; serum bilirubin and alkaline phosphatase \<2x ULN.

You may not qualify if:

• Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.
• Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible.
• Previous treatment with other genetically engineered PSMA-specific CAR T cells or antibody therapy.
• Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
• Patients who require systemic corticosteroid or other immunosuppressive therapy.
• Evidence of tumor potentially causing airway obstruction.
• Inability to comply with protocol requirements.
• Insufficient CAR T cells availability.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead
• Shenzhen Children's Hospital: collaborator
• The Seventh Affiliated Hospital of Sun Yat-sen University: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator

Study Sites (4)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518101, China

RECRUITING

The Seventh Affilliated Hospital of Sun Yat-Sen University

Shenzhen, Guangdong, 518107, 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: January 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)