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

Primary Purpose

B-cell Acute Lymphoblastic Leukemia, Lymphoma, Myeloid Leukemia

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CAR-T cell immunotherapy

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

4 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
Patients must be willing to sign an informed consent.
age: 4 to 70 years
Estimated survival of ≥ 12 weeks, but ≤ 2 years
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 .
Subjects with solid tumor must have measureable disease
Routine blood test：hemoglobin>=90 g/L; platelet>=50×10^9/L.
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(patients with liver cancer were excluded)
Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
ECOG score ≤2
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.

Exclusion Criteria:

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

Sites / Locations

The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T cell immunotherapy

Arm Description

Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.

Outcomes

Primary Outcome Measures

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

Safety evaluation

Secondary Outcome Measures

Clinical response

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

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.

Full Information

NCT ID

NCT03638206

First Posted

August 16, 2018

Last Updated

December 10, 2019

Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

The First Affiliated Hospital of Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT03638206

Brief Title

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

Official Title

Autologous Immunotherapy With Multi-target Gene-modified CAR-T/TCR-T Cell for Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

The First Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAR-T cell immunotherapy

Arm Type

Experimental

Arm Description

Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.

Intervention Type

Biological

Intervention Name(s)

CAR-T cell immunotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Safety evaluation

Time Frame

60 months

Secondary Outcome Measure Information:

Title

Clinical response

Description

Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging.

Time Frame

60 months

Title

CAR-T cells testing

Description

Time Frame

60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: If patients had receive immunotherapy, they should reach PR/NR, or recurrency. Patients must be willing to sign an informed consent. age: 4 to 70 years Estimated survival of ≥ 12 weeks, but ≤ 2 years 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 . Subjects with solid tumor must have measureable disease Routine blood test：hemoglobin>=90 g/L; platelet>=50×10^9/L. 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(patients with liver cancer were excluded) Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%. ECOG score ≤2 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. Exclusion Criteria: ECOG >= 3 Patients with history of T cell tumors Patients with severe insufficient cardiac, pulmonary and hepatorenal functions Acute or chronic GVHD after allogeneic hematopoiesis steroid hormoneswere used before and after blood collection and infusion HIV infection or active hepatitis B or hepatitis C infection Uncontrolled active infection Enrolled to other clinical study in the last 4 weeks. Subjects with systemic auto-immune disease or immunodeficiency. Subjects with CNS diseases. Other patients that researchers considered unsuitable for inclusion

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ZhongHua Yang

Phone

18938688105

zh.yang@bindebio.com

Facility Information:

Facility Name

The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Zhang, MD, PhD

Phone

86-15138928971

yizhang@zzu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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