PSMA-specific CAR-T Cell Therapy

STATUS

Recruiting
participants needed

100
sponsor

Shenzhen Geno-Immune Medical Institute

Updated on 19 February 2024

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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
Age	1years - 75years
Treatment	4SCAR-PSMA T cells
Clinical Study Identifier	NCT04429451
Sponsor	Shenzhen Geno-Immune Medical Institute
Last Modified on	19 February 2024

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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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PSMA-specific CAR-T Cell Therapy

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