PSMA-specific CAR-T Cell Therapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    100
  • sponsor
    Shenzhen Geno-Immune Medical Institute
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Updated on 24 January 2021
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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.

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.

Details
Condition PSMA Positive Tumors or Tumor Tissues
Treatment 4SCAR-PSMA T cells
Clinical Study IdentifierNCT04429451
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on24 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
\. Renal function: Patients must have serum creatinine less than 3 times
upper limit of normal
\. 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)
\. 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
\. For all patients enrolled in this study, themselves or their parents or
legal guardians must sign an informed consent and assent

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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