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Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies

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ClinicalTrials.gov Identifier: NCT03638206
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Shenzhen BinDeBio Ltd.

Study Description
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Brief Summary:
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Lymphoma Myeloid Leukemia Multiple Myeloma Hepatoma Gastric Cancer Pancreatic Cancer Mesothelioma Colorectal Cancer Esophagus Cancer Lung Cancer Glioma Melanoma Synovial Sarcoma Ovarian Cancer Renal Carcinoma Biological: CAR-T cell immunotherapy Phase 1 Phase 2

Detailed Description:
The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include ten different tumor-specific antibody.They are as following:anti-CD19 antibody for B cell leukemia and lymphoma;anti-CD22 antibody for B cell leukemia and lymphoma;anti-CD33 antibody for myeloid leukemia;anti-BCMA antibody for multiple myeloma;anti-CD38 antibody for multiple myeloma;anti-NY-ESO-1 antibody for multiple myeloma,esophagus cancer,lung cancer,melanoma and synovial sarcoma;anti-DR5 antibody for hepatoma;anti-C-met antibody for hepatoma,colorectal cancer,ovarian cancer and renal carcinoma;anti-EGFR V III antibody for hepatoma,lung cancer and glioma;anti-Mesothelin antibody for gastric cancer,pancreatic cancer and mesothelioma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
 Biological: CAR-T cell immunotherapy
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]
    Safety evaluation


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 60 months ]
    Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging.

  2. CAR-T cells testing [ Time Frame: 60 months ]
    The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
  2. Patients must be willing to sign an informed consent.
  3. age: 4 to 70 years
  4. Estimated survival of ≥ 12 weeks, but ≤ 2 years
  5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A*0201 is required at the same time .
  6. Subjects with solid tumor must have measureable disease
  7. Routine blood test：hemoglobin>=90 g/L; platelet>=50×10^9/L.
  8. Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
  9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
  10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
  11. ECOG score ≤2
  12. Adequate venous access for apheresis, and no other contraindications for leukapheresis
  13. Women of child-bearing age must have evidence of negative pregnancy test.
  14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.

Exclusion Criteria:

  1. ECOG >= 3
  2. Patients with history of T cell tumors
  3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
  4. Acute or chronic GVHD after allogeneic hematopoiesis
  5. steroid hormoneswere used before and after blood collection and infusion
  6. HIV infection or active hepatitis B or hepatitis C infection
  7. Uncontrolled active infection
  8. Enrolled to other clinical study in the last 4 weeks.
  9. Subjects with systemic auto-immune disease or immunodeficiency.
  10. Subjects with CNS diseases.
  11. Other patients that researchers considered unsuitable for inclusion
Contacts and Locations
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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): NCT03638206


Contacts
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Contact: ZhongHua Yang 18938688105 zh.yang@bindebio.com

Locations
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China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Yi Zhang, MD, PhD    86-15138928971    yizhang@zzu.edu.cn   
Sponsors and Collaborators
Shenzhen BinDeBio Ltd.
The First Affiliated Hospital of Zhengzhou University
More Information
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Responsible Party: Shenzhen BinDeBio Ltd.
ClinicalTrials.gov Identifier: NCT03638206     History of Changes
Other Study ID Numbers: 2018ZDYFY-BinDeDBD
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burkitt Lymphoma
Leukemia
Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Mesothelioma
Sarcoma, Synovial
Esophageal Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Gastrointestinal Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue
Urogenital Neoplasms