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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03941626

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted July 11, 2019

Study Description

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:Hepatoma
    Gastric Cancer
    Esophagus Cancer
    Glioma
  • Intervention/Treatment: Biological: CAR-T/TCR-T cells immunotherapy
  • Phase: Phase 1/Phase 2
Detailed Description

The study is a multi-target gene-modified immunotherapy. CAR-T/TCR-T cells include four different tumor-specific antibody.They are as following:anti-NY-ESO-1 antibody foresophagus cancer;anti-DR5 antibody for hepatoma;;anti-EGFR vIII antibody for hepatoma and glioma;anti-Mesothelin antibody for gastric cancer.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: EGFRvIII/DR5/NY-ESO-1/Mesothelin CAR-T/TCR-T Cells Immunotherapy for Solid Malignancies
  • Estimated Study Start Date: September 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: CAR-T/TCR-T cells 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/TCR-T cells 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
  • Primary Outcome Measures: 1. Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 48 months ]
    Safety evaluation
  • Secondary Outcome Measures: 1. Clinical response [ Time Frame: 48 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Patients must be willing to sign an informed consent.

2. Male or female patients aged 18 to 70 years .

3. Estimated survival of ≥ 12 weeks.

4. Pathological sections with positive expression of NY-ESO-1, Mesothelin, EGFRvIII and
DR5 was confirmed by biopsy IHC test within 12 months.If NY-ESO-1 is positive
expression ,positive HLAA*0201 is required at the same time.

5. Solid tumor must have at least one measureable disease according to RECIST 1.1.

6. Routine blood test#hemoglobin>=90 g/L; platelet>=50×10^9/L.

7. Liver function:ALT and AST≤2.5 times upper limits of normal (If the tumor infiltration
is the main cause of abnormal liver function ,ALT and AST≤5 times upper limits of
normal); bilirubin=55%.

11. ECOG score:0-1.

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. Subjects of
reproductive potential must agree to use acceptable birth control methods within 1
year after treatment, as described in protocol.

14. Subjects with hypertension/diabetes must be stable blood pressure/blood glucose or
≤CTCAE 1 level 2 weeks before the screening.

In addition to the above criteria for inclusion, the following criteria shall be met
according to the indications:

Patients with glioblastoma:

1. First disease progression or disease recurrence (≥ 1 cm and ≤ 5 cm) of a
supratentorial WHO grade IV malignant glioma (GBM or gliosarcoma) based on imaging
studies with measurable disease.

2. EGFRvIII, the target antigen, must be identified on tumor tissue by IHC or PCR, i.e.
EGFRvIII positive via pathology report.

3. Insensitivity to chemoradiotherapy or chemoradiotherapy failure after operation
molecular pathology.

4. Refused to receive radiotherapy or chemotherapy treatment.

Patients with liver cancer

1. DR5 or EGFRvIII positive via pathology report.

2. Untreatable by surgery ; Or postoperative recurrence ;Or no effective treatment.

3. Liver function:child-pugh A grade or child-pugh B grade.

Patients with gastric cancer

1. Mesothelin positive via pathology report.

2. The pathological stage:IIIA~IV.

3. chemoradiotherapy failure

4. Refused or unable to get surgery.

Patients with esophageal cancer

1. NY-ESO-1 positive via pathology report and HLA-A*0201 positive in blood.

2. Refuse or unable to get surgery.

3. Postoperative recurrence or chemoradiotherapy failure.

Exclusion Criteria:

1. ECOG≥2.

2. malignant tumor cells with T cell origin via pathology test.

3. Organ failure: stage III or IV congestive heart failure; Renal failure and uremia;
respiratory failure; disturbance of consciousness.

4. Acute or chronic GVHD after allogeneic hematopoiesis; Or being treated for GVHD; Or
hormone or immunosuppressant used within 30 days

5. steroid hormoneswere used before and after blood collection and infusion

6. Patients with HIV infection or active hepatitis

7. Uncontrolled active infection.

8. Enrolled to other clinical study in the last 4 weeks.

9. Patients with systemic auto-immune disease or immunodeficiency.

10. Patients with neuropathy or psychosis, including dementia or epilepsy, or history of
psychotropic substance abuse, or other substantial lesions that may increase central
neurotoxicity.

11. Concomitant with the second tumor or other malignant tumors.

12. Patients with bone metastases are at risk of a pathological fracture resulting in
paraplegia or life threatening.

13. Live attenuated vaccine was administered within 4 weeks prior to blood collection.

14. Blood oxygen saturation is maintained by oxygen inhalation.

15. Received major surgery within 2 weeks prior to screening ;Or Plan to receive surgery
during study or within 2 weeks after injection.

16. Other patients that researchers considered unsuitable for inclusion.

Contacts and Locations
Contacts

Contact: ZHONG HUA YANG +8618938688105 ext +8618938688105 zh.yang@bindebio.com

Locations

China, Henan
Henan Provincial People's Hospital
Zhengzhou

Sponsors and Collaborators

Shenzhen BinDeBio Ltd.

Henan Provincial People's Hospital

More Information
  • Responsible Party: Shenzhen BinDeBio Ltd.
  • ClinicalTrials.gov Identifier: NCT03941626 History of Changes
  • Other Study ID Numbers: 2019BDB016
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: July 11, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Esophageal Neoplasms