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Esophagus CancerPhase 1/2NCT03941626

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

A Phase 1/2 study testing CAR-T/TCR-T cells immunotherapy in people with Esophagus Cancer and Hepatoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 18 to 70 years
Conditions the study is for
Esophagus Cancer, Hepatoma, Glioma
What is being tested?
CAR-T/TCR-T cells immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Sep 2019to 1 Dec 2021
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • In addition to the above criteria for inclusion, the following criteria shall be met according to the indications:
  • Patients with glioblastoma：
  • First disease progression or disease recurrence (≥ 1 cm and ≤ 5 cm) of a supratentorial WHO grade IV malignant glioma (GBM or gliosarcoma) based on imaging studies with measurable disease.
  • EGFRvIII, the target antigen, must be identified on tumor tissue by IHC or PCR, i.e. EGFRvIII positive via pathology report.
  • Insensitivity to chemoradiotherapy or chemoradiotherapy failure after operation molecular pathology.
  • Refused to receive radiotherapy or chemotherapy treatment.
  • Patients with liver cancer
  • DR5 or EGFRvIII positive via pathology report.
  • Untreatable by surgery ; Or postoperative recurrence ;Or no effective treatment.
  • Liver function：child-pugh A grade or child-pugh B grade.
  • Patients with gastric cancer
  • Mesothelin positive via pathology report.
  • The pathological stage：IIIA～IV.
  • chemoradiotherapy failure
  • Refused or unable to get surgery.
  • Patients with esophageal cancer
  • NY-ESO-1 positive via pathology report and HLA-A*0201 positive in blood.
  • Refuse or unable to get surgery.
  • Postoperative recurrence or chemoradiotherapy failure.

Who cannot join

  • 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
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  • 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.
  • Other patients that researchers considered unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

ZHONG HUA YANG contact

+8618938688105 ext. +8618938688105

zh.yang@bindebio.com

China1 site, 1 recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450052

    Shuangyin Han, +8613203710057, hansyzzu@163.com

    Chun-Xiao Ma, +8615038287266, chxma@126.com

    Recruiting

Other trials in China

About this study

Official title: EGFRvIII/DR5/NY-ESO-1/Mesothelin CAR-T/TCR-T Cells Immunotherapy for Solid 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 four different tumor-specific antibody.They are as following:anti-NY-ESO-1 antibody foresophagus cancer;anti-DR5 antibody for hepatoma;;anti-EGFR vIII antibody for hepatoma and glioma;anti-Mesothelin antibody for gastric cancer.

Being tested
CAR-T/TCR-T cells immunotherapy
Medical subject headings
Esophageal Neoplasms, Carcinoma, Hepatocellular, Glioma, Stomach Neoplasms

What participants receive

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

  • CAR-T/TCR-T cells 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 NCT03941626
Study groupRoleWhat they receive
CAR-T/TCR-T cells 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/TCR-T cells 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: 48 months

Secondary outcomes (1)

  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: 48 months

Timeline

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

  1. First posted8 May 2019
  2. Study start1 Sep 2019
  3. Primary completion1 May 2021 (estimated)
  4. Study completion1 Dec 2021 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941626
Sponsor's protocol ID
2019BDB016
Status last verified
Feb 2021
First submitted
6 May 2019
Last updated
4 Feb 2021
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/TCR-T cells immunotherapy in people with Esophagus Cancer and Hepatoma, 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 33 inclusion and 16 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 4 Feb 2021. 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 ZHONG HUA YANG (+8618938688105 ext. +8618938688105, 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: 48 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 NCT03941626.

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 4 Feb 2021.

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