ImmunotherapyPhase 1NCT03619954
NK Cells Infusion for Advanced Malignancies
A Phase 1 study testing NK cells infusion in people with Immunotherapy, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunotherapy
- What is being tested?
- NK cells infusion
- 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 Jul 2018to 1 Jul 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced malignant tumors diagnosed by pathological histology and/or cytology who have failed multi-line therapy and have no standard treatment method are unable to undergo surgery, radiation therapy, or chemotherapy;
- Age 18-75 years old (≥18, ≤75);
- ECOG: 0-1;
- Priority should be given to the inclusion of ovarian cancer, malignant leukemia, lymphoma, etc. that have been shown to respond well to NK cell therapy;
- Expected survival period ≥ 3 months;
- Hematology tests also meet the following requirements:
- 1) WBC≥3×109/L, ANC≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L; 2) TBIL ≤ 1.5 × ULN (normal upper limit), ALT and AST ≤ 2 × ULN (if there is liver metastasis, then ≤ 5 × ULN); 3) Endogenous creatinine clearance ≥ 60 ml/min (calculated based on Cockcroft-Gault formula); (7) Length of solid tumors do not exceed 6 cm; (8) Signing of informed consent from each patient
Who cannot join
- History of other malignancies with a disease-free period <5 years (except for cured basal cell carcinoma of the skin, cured carcinoma of the cervix in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
- Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);
- Transplant recipients;
- T-cell lymphoma patients;
- Allergies to biologics used in this treatment;
- Patients with HIV and syphilis;
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- HBV carriers;
- Patients who are undergoing radiation therapy or immunotherapy within 4 weeks;
- Patients who have undergone high-dose radiation therapy on the lung and liver within 4 months;
- Patients with pulmonary inflammation determined by chest radiography;
- Oxygen saturation ≤ 90% on room air;
- Patients with cachexia caused by advanced tumors;
- Long-term use of immunosuppressive drugs or patients who are using immunosuppressive drugs;
- Those with serious autoimmune diseases;
- Patients with organ failure (grade 4 of heart function; liver function with Child class C or above; brain metastasis with disturbance of consciousness; severe respiratory failure symptoms);
- Active infections (including intra-abdominal infections).
- Researchers consider it inappropriate to participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial cancer center
Hefei, Anhui, 230001
Yue-Yin Pan, PhD, 0086-551-62283411, yueyinpan1965@163.com
Wei Wang, MD, 0086-551-62283411, whouwei@gmail.com
About this study
Official title: A Clinical Research of Natural Killer (NK) Cells Infusion for the Treatment of Advanced Malignant Tumor
This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients
- Conditions
- Immunotherapy
- Being tested
- NK cells infusion
- Keywords
- NK cell infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cells infusionBiological
Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment.
NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times
| Study group | Role | What they receive |
|---|---|---|
| NK cells infusion | Experimental | Not described Receives: Biological: NK cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful expansion of NK cells in patient's circulatory system
CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells
Measured: 7 days after the last treatment
Objective Response Rate
The percentage of patients who reach complete response（CR）or partial response （PR）after all treatment finished. The response is evaluated according to irRECIST.
Measured: 4 weeks after all the treatment finished
Secondary outcomes (3)
Overall survival
The interval time from the date when patients are enrolled into study to death or the last visit
Measured: 1 and 2 years after treatment
Disease progression free survival
The interval time from the date when patients are enrolled into study to disease progression, death or last visit
Measured: 1 and 2 years after treatment
Dynamic changes of NK cells number in blood
Numbers of CD56 positive cell in peripheral blood
Measured: Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yue-Yin Pan, Anhui Provincial Hospital
- Investigators
- Yueyin Pan, PhD, Principal investigator, Anhui Province Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619954
- Sponsor's protocol ID
- AHP2018070101
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research of Natural Killer (NK) Cells Infusion for the Treatment of Advanced Malignant Tumor
- ClinicalTrials.gov ID
- NCT03619954
- Acronym / sponsor ID
- AHP2018070101
- Conditions
- Immunotherapy
- Keywords
- NK cell infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 8 Aug 2018 (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.
This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK cells infusion | Experimental | Biological: NK cells infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with advanced malignant tumors diagnosed by pathological histology and/or cytology who have failed multi-line therapy and have no standard treatment method are unable to undergo surgery, radiation therapy, or chemotherapy;
- Age 18-75 years old (≥18, ≤75);
- ECOG: 0-1;
- Priority should be given to the inclusion of ovarian cancer, malignant leukemia, lymphoma, etc. that have been shown to respond well to NK cell therapy;
- Expected survival period ≥ 3 months;
Key exclusion criteria (17 listed)
- History of other malignancies with a disease-free period <5 years (except for cured basal cell carcinoma of the skin, cured carcinoma of the cervix in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
- Patients with brain metastases (unless the investigator believes that brain metastasis is currently stable, it is generally not recommended for enrollment);
- Transplant recipients;
- T-cell lymphoma patients;
- Allergies to biologics used in this treatment;
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 |
|---|---|---|
| NK cells infusionPretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment. NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times | Biological | NK cells infusion |
Primary outcome
Successful expansion of NK cells in patient's circulatory system
Time frame: 7 days after the last treatment
CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells
Objective Response Rate
Time frame: 4 weeks after all the treatment finished
The percentage of patients who reach complete response（CR）or partial response （PR）after all treatment finished. The response is evaluated according to irRECIST.
3 secondary outcomes
Overall survival
Time frame: 1 and 2 years after treatment
Disease progression free survival
Time frame: 1 and 2 years after treatment
Dynamic changes of NK cells number in blood
Time frame: Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yueyin Pan, PhD principal investigator
Anhui Province Cancer Center
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 NK cells infusion in people with Immunotherapy, run by Anhui Provincial 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 7 inclusion and 17 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 8 Aug 2018. 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 Yueyin Pan, PhD (86-551-62283411, yueyinpan1965@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful expansion of NK cells in patient's circulatory system (time frame: 7 days after the last 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 8 Aug 2018.