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Trial record 1 of 1 for:    NCT04429451
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PSMA-specific CAR-T Cell Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04429451
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Shenzhen Children's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Hospital of Southern Medical University
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

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.

Condition or disease Intervention/treatment Phase
PSMA Positive Tumors or Tumor Tissues Biological: 4SCAR-PSMA T cells Phase 1 Phase 2

Detailed Description:

Prostate-specific membrane antigen (PSMA) is expressed in normal prostate and is upregulated in prostate tumor. Therefore, PSMA is a promising target for antigen-specific immunotherapy in patients with prostate cancer. However, it has been reported that PSMA expression is not restricted to prostate cancer and PSMA is often enriched in the tumor stromal environment. By immunostaining, we found that PSMA is expressed in a variety of solid tumors, including brain tumor, neuroblastoma and some lymphoma tumor tissues.

This study aims to use T cells obtained directly from the patient, which can be genetically modified to express PSMA-specific chimeric antigen receptor (CAR). The CAR molecules enable the T cells to recognize and kill tumor cells or tumor stromal tissues through the recognition of a surface antigen, PSMA. This study will evaluate the side effects and the best dose of anti-PSMA CAR-T cells to target PSMA positive tumors and tumor microenvironment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial of 4SCAR-PSMA T Cell Therapy Targeting PSMA Positive Malignancies
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: 4SCAR-PSMA Cell Therapy for PSMA positive tumor
Infusion of 4SCAR-PSMA T cells at 10^6 cells/kg body weight via IV
Biological: 4SCAR-PSMA T cells
Infusion of 4SCAR-PSMA T cells at 10^6 cells/kg body weight via IV

Primary Outcome Measures :
  1. Number of patients with adverse events. [ Time Frame: 3 year ]
    Determine the toxicity profile the 4SCAR-PSMA cells with Common Toxicity Criteria for Adverse Effects version 4.0

Secondary Outcome Measures :
  1. Anti-tumor effects [ Time Frame: 1 year ]
    Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

  2. The expansion and persistence of 4SCAR-PSMA T cells [ Time Frame: 1 year ]
    Scale of CAR copies and tumor burden (for efficacy)

  3. Survival time of the patients [ Time Frame: 3 year ]
    The survival time of the patients treated with the 4SCAR-PSMA T cells, including progression free survival (PFS) and overall survival (OS) will be evaluated.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent.
  2. 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.
  3. Body weight greater than or equal to 10 kg.
  4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
  5. Life expectancy: at least 8 weeks.
  6. 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.

  7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.
  8. 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.
  9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.
  10. At least 1 week since any radiation therapy at the time of study entry.
  11. Karnofsky/jansky score of 60% or greater.
  12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent.
  13. Pulse Ox greater than or equal to 90% on room air.
  14. 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.
  15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.
  16. Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion).
  17. Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity.
  18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.

Exclusion Criteria:

  1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.
  2. 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.
  3. Previous treatment with other genetically engineered PSMA-specific CAR T cells or antibody therapy.
  4. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
  5. Patients who require systemic corticosteroid or other immunosuppressive therapy.
  6. Evidence of tumor potentially causing airway obstruction.
  7. Inability to comply with protocol requirements.
  8. Insufficient CAR T cells availability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04429451

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China, Guangdong
Shenzhen Children's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Sixi Liu, MD    86-189 3869 0206   
Contact: Xiuli Yuan, MD    86-18938690212   
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195   
Shenzhen Hospital of Southern Medical University Recruiting
Shenzhen, Guangdong, China, 518101
Contact: Jie Mao, MD    86-0755-233   
The Seventh Affilliated Hospital of Sun Yat-Sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Bo Wang, MD    86-0755-23242570   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Shenzhen Children's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Hospital of Southern Medical University
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute Identifier: NCT04429451    
Other Study ID Numbers: GIMI-IRB-20003
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
chimeric antigen receptor
adoptive T cell transfer
Prostate cancer
Tumor microenvironment