Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04864821
Recruitment Status : Not yet recruiting
First Posted : April 29, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 cells or tissues. In conclusion, car-t cell therapy has achieved exciting results in blood tumors, but it has been stopped in solid tumor. The main reason for the poor effect is the existence of tumor microenvironment of solid tumor, which inhibits the chemotaxis and infiltration of car-t cells to tumor site. Therefore, in this clinical experiment, we will explore the best model of car-t therapy for solid tumor by intravenous and local tumor injection, which will bring new hope to patients with osteosarcoma, neuroblastoma and gastric cancer

Condition or disease Intervention/treatment Phase
Osteosarcoma Neuroblastoma Gastric Cancer Lung Cancer Drug: Targeting CD276 CAR T cells Early Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of CD276 Targeted Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With CD276 Positive Advanced Solid Tumor
Estimated Study Start Date : May 14, 2021
Estimated Primary Completion Date : May 14, 2022
Estimated Study Completion Date : May 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
T cell injection targeting CD276 chimeric antigen receptor Drug: Targeting CD276 CAR T cells
Targeting CD276 autologous chimeric antigen receptor T cells


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. AE [ Time Frame: 2 years after treatment ]
    adverse event

  2. ORR [ Time Frame: 12 weeks after treatment ]
    Objective remission rate

  3. Cmax [ Time Frame: 2 years after treatment ]
    The highest concentration of CAR-T cells in peripheral blood after infusion


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Urea and serum creatinine ≤ 1.5 × ULN；
    2. Left ventricular ejection fraction ≥ 50%;
    3. Baseline oxygen saturation ≥ 94%;
    4. 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 Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864821


Contacts
Layout table for location contacts
Contact: Yi Zhang, Doctor +8615138928971 1248135168@qq.com

Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The First Affiliated Hospital of Zhengzhou University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04864821    
Other Study ID Numbers: PA-P276-001
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroblastoma
Osteosarcoma
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma