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Status unknownNCT03692637Updated Jan 31, 2019

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

An Early Phase 1 interventional study of anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer, sponsored by Allife Medical Science and Technology Co., Ltd.. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Allife Medical Science and Technology Co., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Epithelial Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Allife Medical Science and Technology Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.(Mesothelin expression ≥50% of tumor cells)(Patients with recurrence are not excluded)
  2. Male or female, 18 to 70 years old (including 18 and 70 years old)
  3. The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points
  4. there are measurable lesions according to the RECIST 1.1 standard.
  5. 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
  6. Coagulation parameters: INR ≤ 1.5, PTT \< 1.2 times the upper limt
  7. 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)
  8. Venous channel is unobstructed, which can meet the needs of intravenous drip
  9. HIV test was negative; HBV and HCV were negative
  10. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Patients suffer from concurrent or central nervous system diseases
  3. Patients with severe autoimmune diseases or immunodeficiency diseases
  4. 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%
  5. Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
  6. Patients with Severe liver and kidney dysfunction
  7. Patients with Severe bacterial and viral infections
  8. Patients are pregnant or nursing
  9. Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone)
  10. Patients participated in other clinical trials within 30 days.
  11. Patients had other conditions that were not appropriate for the group determined by the researchers.
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Study design

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

Study arms

  • Experimental
    anti-Mesothelin Car NK Cells

    Total dose of 0.5-3 million /kg cells will be administered at day0

    Biological: anti-Mesothelin Car NK Cells

Interventions

  • Biologicalanti-Mesothelin Car NK Cells

    anti-Mesothelin Car NK Cells injection

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What researchers measure

Primary outcomes

  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

    Time frame: Day 3-Year 2 after injection

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03692637
Lead sponsor
Allife Medical Science and Technology Co., Ltd.
Responsible party
Sponsor
First posted
Oct 2, 2018
Start date
Mar 2019 (estimated)
Primary completion
Nov 2020 (estimated)
Completion
Nov 2021 (estimated)
Last update
Jan 31, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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