Status:
UNKNOWN
CD276 CAR-T for Patients With Advanced CD276+ Solid Tumors
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
CAR
Solid Tumor
Eligibility:
All Genders
3-70 years
Phase:
NA
Brief Summary
This study is a clinical study of CD276 CAR-T in the treatment of patients with advanced solid tumors. The purpose is to evaluate the safety and effectiveness of targeting CD276 auto-chimeric antigen ...
Eligibility Criteria
Inclusion
- Age 3-70
- Expected survival time ≥ 12weeks
- ECOG 0-2
- At least second-line or above chemotherapy failed
- According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion (non-nodular lesion with longest diameter ≥10mm, or nodular lesion with short diameter ≥15mm)
- Liver and kidney function, heart and lung function meet the following requirements:
- Creatinine is within the normal range;
- Left ventricular ejection fraction ≥ 45%;
- Baseline blood oxygen saturation\>91%;
- Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN
- Understand the trial and have signed the informed consent
Exclusion
- Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
- Severe heart disease
- Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
- Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
- Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 1 year after cell reinfusion, or male subjects whose partners plan to become pregnant within 1 year after cell reinfusion
- Those who have received CAR-T therapy or other genetically modified cell therapy before screening
- Subjects who are receiving systemic steroid therapy at the time of screening and the investigator determines that they need long-term systemic steroid therapy during the treatment period (except for inhaled or topical use)
- Participated in other clinical studies within 3 months before screening
- Central nervous system metastases are known to occur and for suspected central nervous system metastases, head MRI examination is required to rule out
- Patients with partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved by active treatment
- With more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase
- According to the researcher's judgment, it does not meet the situation of cell preparation
- Situations that other researchers think are not suitable for inclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04691713
Start Date
September 1 2019
End Date
December 1 2021
Last Update
December 31 2020
Active Locations (1)
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1
Bin Hu Hospital
Hefei, Anhui, China, 230601