Status:
UNKNOWN
PSMA-specific CAR-T Cell Therapy
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
Shenzhen Children's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
Conditions:
PSMA Positive Tumors or Tumor Tissues
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
PHASE2
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 mor...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04429451
Start Date
January 1 2020
End Date
December 31 2024
Last Update
June 12 2020
Active Locations (4)
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1
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China, 518101
4
The Seventh Affilliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107