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B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT03638206

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

A Phase 1/2 study testing CAR-T cell immunotherapy in people with B-cell Acute Lymphoblastic Leukemia and Lymphoma, run by Shenzhen BinDeBio Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 4 to 70 years
What is being tested?
CAR-T cell immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
1 Mar 2018to 1 Mar 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

ZhongHua Yang contact

18938688105

zh.yang@bindebio.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yi Zhang, MD, PhD, 86-15138928971, yizhang@zzu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Being tested
CAR-T cell immunotherapy
Medical subject headings
Burkitt Lymphoma, Lymphoma, Leukemia, Myeloid, Multiple Myeloma, Carcinoma, Hepatocellular, Stomach Neoplasms, Pancreatic Neoplasms, Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR-T cell immunotherapyBiological

    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.

Study groups in NCT03638206
Study groupRoleWhat they receive
CAR-T cell immunotherapyExperimentalEnrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.
Receives: Biological: CAR-T cell immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Safety evaluation

    Measured: 60 months

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start1 Mar 2018
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03638206
Sponsor's protocol ID
2018ZDYFY-BinDeDBD
Status last verified
Dec 2019
First submitted
16 Aug 2018
Last updated
11 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T cell immunotherapy in people with B-cell Acute Lymphoblastic Leukemia and Lymphoma, run by Shenzhen BinDeBio Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ZhongHua Yang (18938688105, zh.yang@bindebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03638206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.

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