Status:
UNKNOWN
Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
Sun Yat-sen University
Shenzhen Children's Hospital
Conditions:
Solid Tumor
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. This study attempts to treat these dis...
Detailed Description
Background: Patients with refractory and/or recurrent solid tumors have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators are attemp...
Eligibility Criteria
Inclusion
- Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
- The CD276 antigen status of the tumor is determined for eligibility. Positive expression is defined by antibody staining results based on immunohistochemistry or flow cytometry analysis.
- 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: 1) 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. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) 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 not evaluable to 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 grade 3 hematologic toxicity.
- Untreated central nervous system (CNS) metastasis: Patients with CNS tumor involvement that has been treated and/or is stable for at least 6 weeks following completion of therapy are eligible.
- Previous treatment with other genetically engineered CD276-CAR T cells or CD276 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 :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04432649
Start Date
June 1 2020
End Date
May 31 2024
Last Update
June 16 2020
Active Locations (3)
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1
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107