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

NCT03941626 | Unknown Phase 1 DMC

• 1 other identifier: 2019BDB016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer; Hepatoma; Glioma; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0

  Safety evaluation

  48 months

Secondary Outcomes (1)

• Clinical response

  48 months

Study Arms (1)

CAR-T/TCR-T cells immunotherapy

EXPERIMENTAL

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

Interventions

CAR-T/TCR-T cells immunotherapy BIOLOGICAL

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.

CAR-T/TCR-T cells immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be willing to sign an informed consent.
• Male or female patients aged 18 to 70 years .
• Estimated survival of ≥ 12 weeks.
• 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.
• Solid tumor must have at least one measureable disease according to RECIST 1.1.
• Routine blood test#hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
• 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\<2.0 mg/dL.
• Renal function:BUN: 9-20mg / dl; serum creatinine≤ 1.5 times upper limits of normal; endogenous creatinine clearance rate≥50 ml/min .
• Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
• Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
• ECOG score:0-1.
• Adequate venous access for apheresis, and no other contraindications for leukapheresis .
• 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.
• Subjects with hypertension/diabetes must be stable blood pressure/blood glucose or ≤CTCAE 1 level 2 weeks before the screening.
• Patients with glioblastoma：

You may not qualify if:

• ECOG≥2.
• malignant tumor cells with T cell origin via pathology test.
• Organ failure: stage III or IV congestive heart failure; Renal failure and uremia; respiratory failure; disturbance of consciousness.
• Acute or chronic GVHD after allogeneic hematopoiesis; Or being treated for GVHD; Or hormone or immunosuppressant used within 30 days
• steroid hormoneswere used before and after blood collection and infusion
• Patients with HIV infection or active hepatitis
• Uncontrolled active infection.
• Enrolled to other clinical study in the last 4 weeks.
• Patients with systemic auto-immune disease or immunodeficiency.
• Patients with neuropathy or psychosis, including dementia or epilepsy, or history of psychotropic substance abuse, or other substantial lesions that may increase central neurotoxicity.
• Concomitant with the second tumor or other malignant tumors.
• Patients with bone metastases are at risk of a pathological fracture resulting in paraplegia or life threatening.
• Live attenuated vaccine was administered within 4 weeks prior to blood collection.
• Blood oxygen saturation is maintained by oxygen inhalation.
• Received major surgery within 2 weeks prior to screening ;Or Plan to receive surgery during study or within 2 weeks after injection.

Sponsors & Collaborators

• Shenzhen BinDeBio Ltd.: lead
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Carcinoma, Hepatocellular; Glioma; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Stomach Diseases

Central Study Contacts

ZHONG HUA YANG

CONTACT

+8618938688105; zh.yang@bindebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)