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 : December 11, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 73 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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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. |
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 [ Time Frame: 60 months ]Safety evaluation
- 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.

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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 |
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

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
Contact: ZhongHua Yang | 18938688105 | zh.yang@bindebio.com |
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 |
Responsible Party: | Shenzhen BinDeBio Ltd. |
ClinicalTrials.gov Identifier: | NCT03638206 |
Other Study ID Numbers: |
2018ZDYFY-BinDeDBD |
First Posted: | August 20, 2018 Key Record Dates |
Last Update Posted: | December 11, 2019 |
Last Verified: | December 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 |
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 Leukemia, Lymphoid |