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Status unknownNCT03638206Updated Dec 11, 2019

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

A Phase 1/2 interventional study of CAR-T cell immunotherapy in B-cell Acute Lymphoblastic Leukemia, Lymphoma and Myeloid Leukemia, sponsored by Shenzhen BinDeBio Ltd.. Status unknown at 1 site in China. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Shenzhen BinDeBio Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
4 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
4 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (estimated)

Study arms

  • 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.

    Biological: CAR-T cell immunotherapy

Interventions

  • BiologicalCAR-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.

05

What researchers measure

Primary outcomes

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

    Safety evaluation

    Time frame: 60 months

Secondary outcomes

  1. 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.

    Time frame: 60 months

  2. 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.

    Time frame: 60 months

06

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03638206
Lead sponsor
Shenzhen BinDeBio Ltd.
Collaborators
The First Affiliated Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Aug 20, 2018
Start date
Mar 1, 2018
Primary completion
Mar 1, 2023 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Dec 11, 2019

Study contacts

ZhongHua Yang
Contact
zh.yang@bindebio.com
18938688105

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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