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Epithelial Ovarian CancerEarly Phase 1NCT03692637

Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer

A Early Phase 1 study testing anti-Mesothelin Car NK Cells in people with Epithelial Ovarian Cancer, run by Allife Medical Science and Technology Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 centre、single arm、open-label，to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
anti-Mesothelin Car NK Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Mar 2019to Nov 2021
Phase
Early Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.（Mesothelin expression ≥50% of tumor cells）（Patients with recurrence are not excluded）
  • Male or female, 18 to 70 years old (including 18 and 70 years old)
  • The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points
  • there are measurable lesions according to the RECIST 1.1 standard.
  • Bone marrow function (blood routine) satisfies: the number of neutrophils > 1×109/L platelet > 7.5×109/L; hemoglobin > 90 g/L; total bilirubin < 2.0 mg/dL; creatinine < 1.5 times the upper limit; albumin < 2 g/L; ALT or AST < 5 times the upper limit; creatinine clearance rateby Cockcroft-Gault formula< 40 mL/min
  • Coagulation parameters: INR ≤ 1.5, PTT < 1.2 times the upper limt
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  • Patients did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs PD-1, PDL-1) or other anticancer treatment 2-4 weeks before admission, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example）
  • Venous channel is unobstructed, which can meet the needs of intravenous drip
  • HIV test was negative; HBV and HCV were negative
  • Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Who cannot join

  • Patients with hypertension (> 160/95 mmHg) are uncontrollable; coronary heart disease and angina pectoris are unstable (Canadian Cardiovascular Association Level II and above), or recurrent within 6 months
  • Patients suffer from concurrent or central nervous system diseases
  • Patients with severe autoimmune diseases or immunodeficiency diseases
  • Patient's lung function has the following abnormalities: FEV (forced expiratory volume), < 30%; DLCO (diffusing capacity of lung for carbon monoxide) < 30%; oxygen saturation < 90%
  • Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
  • Patients with Severe liver and kidney dysfunction
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  • Patients with Severe bacterial and viral infections
  • Patients are pregnant or nursing
  • Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone)
  • Patients participated in other clinical trials within 30 days.
  • Patients had other conditions that were not appropriate for the group determined by the researchers.

About this study

Official title: Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer

This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer

Read the detailed description

Ovarian cancer ranks second in gynecologic malignancies, but mortality ranks first. It is one of the most serious malignant tumors that threaten women's lives. It is urgent to explore new treatment methods, such as introduction. Tumor immunotherapy strategies to improve treatment outcomes and patient quality of life. Car is a group of fusion proteins composed of multiple parts, including antigen recognition region, transmembrane region, and NK cell stimulation region. NK cells are naive immune cells that are not restricted by MHI and can be activated without additional co-stimulatory regions. After activation, granulin-B and γ-interferon are released, thereby inducing apoptosis of tumor cells and lysis of tumor cells. The study will follow a 3 + 3 design of dose- escalating cohorts. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclearcells which will be sent to a manufacturing site to produce anti-Mesothelin Car NK cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.

Being tested
anti-Mesothelin Car NK Cells
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • anti-Mesothelin Car NK CellsBiological

    anti-Mesothelin Car NK Cells injection

Study groups in NCT03692637
Study groupRoleWhat they receive
anti-Mesothelin Car NK CellsExperimentalTotal dose of 0.5-3 million /kg cells will be administered at day0
Receives: Biological: anti-Mesothelin Car NK Cells

What is being measured

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

  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.0

    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment

    Measured: Day 3-Year 2 after injection

Timeline

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

  1. First posted2 Oct 2018
  2. Study startMar 2019 (estimated)
  3. Primary completionNov 2020 (estimated)
  4. Study completionNov 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692637
Sponsor's protocol ID
Mesothelin Car NK-HNRM-01
Status last verified
Sep 2018
First submitted
29 Sep 2018
Last updated
31 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-Mesothelin Car NK Cells in people with Epithelial Ovarian Cancer, run by Allife Medical Science and Technology Co., Ltd..

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 10 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment related adverse events as assessed by CTCAE v4.0 (time frame: Day 3-Year 2 after injection). 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 NCT03692637.

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 31 Jan 2019.

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