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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.

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date August 20, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]
Safety evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies
Official Title  ICMJE Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: CAR-T cell immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
73
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ZhongHua Yang 18938688105 zh.yang@bindebio.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03638206
Other Study ID Numbers  ICMJE 2018ZDYFY-BinDeDBD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shenzhen BinDeBio Ltd.
Study Sponsor  ICMJE Shenzhen BinDeBio Ltd.
Collaborators  ICMJE The First Affiliated Hospital of Zhengzhou University
Investigators  ICMJE Not Provided
PRS Account Shenzhen BinDeBio Ltd.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP