Status:
UNKNOWN
Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Osteosarcoma
Neuroblastoma
Eligibility:
All Genders
1-70 years
Phase:
EARLY_PHASE1
Brief Summary
Cd276 (B7-H3) is an ideal target for car-t treatment because of its high expression on the surface of neuroblastoma, osteosarcoma, gastric cancer and lung cancer cells, but not in normal peripheral ce...
Eligibility Criteria
Inclusion
- The patients were aged from 1 to 70 years old (including the cut-off value), and the gender was not limited;
- The expected survival time was more than 12 weeks;
- ECoG score was 0-2;
- One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of cd276 expression in tumor tissue was more than 50% by immunohistochemistry;
- Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
- According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion ≥ 10 mm, or the short diameter of lymph node lesion ≥ 15 mm);
- The function of main organs was normal (white blood cell count ≥ 3 × 109 / L, neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 8.5g/dl, platelet count ≥ 80 × 109 / L and lymphocyte count at 1 × 109 / L (including) \~ 4 × 109 / L (inclusive);
- The liver and kidney function and cardiopulmonary function meet the following requirements:
- Urea and serum creatinine ≤ 1.5 × ULN；
- Left ventricular ejection fraction ≥ 50%;
- Baseline oxygen saturation ≥ 94%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN；
- The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.
Exclusion
- Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- There was a history of other second malignancies in 5 years before screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
- Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;
- Patients who had received car-t therapy or other gene modified cell therapy before screening;
- The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;
- The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
- According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- Other researchers think that it is not suitable for inclusion.
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 14 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04864821
Start Date
May 14 2021
End Date
May 14 2023
Last Update
May 6 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.