NK Cell Mediated ImmunityPhase 1NCT03948828
Clinical Study of NK Cells in the Treatment of Severe Endometriosis
A Phase 1 study testing Autologous NK cell therapy and GnRHa combained with reverse addition therapy in people with NK Cell Mediated Immunity and Endometriosis, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- NK Cell Mediated Immunity, Endometriosis
- What is being tested?
- Autologous NK cell therapy and GnRHa combained with reverse addition therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2022
- Phase
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagonsed as endometriosis stage III~IV
- Age ≥18 years ≤ 45 years at the time of informed consent
- With indications for conservative endometriosis surgery
- With complete clinical data
Who cannot join
- Severe allergy to drugs
- Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
- With serious cardiac, cerebrovascular diseases and liver, kidney disorders
- With a history of severe mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Lili Ren, Ph.D, +86-755-22942466, ren.lili@szhospital.com
Min Zhang, Ph.D, +86-755-22942466, zzuzhangmin@163.com
About this study
Official title: Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.
Read the detailed description
Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.
- Conditions
- NK Cell Mediated Immunity, Endometriosis
- Being tested
- Autologous NK cell therapy, GnRHa combained with reverse addition therapy
- Keywords
- Endometriosis, NK cell therapy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous NK cell therapyBiological
After conventional treatment, the patients were treated with autologous NK cells.
GnRHa combained with reverse addition therapyDrug
Also called Conventional treatment
Postoperative patients were treated with GnRHa combined with reverse addition treatment.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Other | GnRHa combained with reverse addition therapy Receives: Drug: GnRHa combained with reverse addition therapy |
| Conventional treatment and Autologous NK cells therapy | Experimental | GnRHa combained with reverse addition therapy and NK cell combined treatment group Receives: Biological: Autologous NK cell therapy; Drug: GnRHa combained with reverse addition therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety]
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
Measured: 3 months after treatment
Purity and Function of NK cells
The purity and function of NK cells will be measured by flow cytometry.
Measured: once per three months
Secondary outcomes (3)
Endocrine hormone levels
The levels of endocrine hormone, including serum estradiol, testosterone, progesterone, luteinizing hormone and follicle stimulating hormone will be measured.
Measured: every three months, up to 36 months
Pain score
A score of 0 means that you have never had this problem, and a score of 100 means that you are always troubled by this problem and feel unbearable. You can choose any number between 0 and 100 to represent your feelings. The higher the score, the worse your feelings will be.
Measured: every three months, up to 36 months
The percent of pregnancy
The pregnancy will be meaured by B ultrasound.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK Cell Mediated ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Qi, M.D, Study director, Shen Zhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948828
- Sponsor's protocol ID
- ShenzhenPH BTR-003
- Status last verified
- May 2019
- First submitted
- 28 Mar 2019
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
- ClinicalTrials.gov ID
- NCT03948828
- Acronym / sponsor ID
- ShenzhenPH BTR-003
- Conditions
- NK Cell Mediated Immunity, Endometriosis
- Keywords
- Endometriosis, NK cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.
Detailed description
Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Other | Drug: GnRHa combained with reverse addition therapyGnRHa combained with reverse addition therapy |
| Conventional treatment and Autologous NK cells therapy | Experimental | Biological: Autologous NK cell therapy, Drug: GnRHa combained with reverse addition therapyGnRHa combained with reverse addition therapy and NK cell combined treatment group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagonsed as endometriosis stage III~IV
- Age ≥18 years ≤ 45 years at the time of informed consent
- With indications for conservative endometriosis surgery
- With complete clinical data
Key exclusion criteria (4 listed)
- Severe allergy to drugs
- Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
- With serious cardiac, cerebrovascular diseases and liver, kidney disorders
- With a history of severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous NK cell therapyAfter conventional treatment, the patients were treated with autologous NK cells. | Biological | Conventional treatment and Autologous NK cells therapy |
| GnRHa combained with reverse addition therapyAlso: Conventional treatmentPostoperative patients were treated with GnRHa combined with reverse addition treatment. | Drug | Conventional treatment and Autologous NK cells therapy, Conventional treatment group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 3 months after treatment
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
Purity and Function of NK cells
Time frame: once per three months
The purity and function of NK cells will be measured by flow cytometry.
3 secondary outcomes
Endocrine hormone levels
Time frame: every three months, up to 36 months
Pain score
Time frame: every three months, up to 36 months
The percent of pregnancy
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Qi, M.D study director
Shen Zhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous NK cell therapy and GnRHa combained with reverse addition therapy in people with NK Cell Mediated Immunity and Endometriosis, run by Shenzhen People's Hospital 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 4 inclusion and 4 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 14 May 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 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.
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 Lili Ren, Ph.D (+86-755-22942466, ren.lili@szhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2019.