Peripheral Blood Mononuclear CellNCT04448509
Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
A study testing Peripheral blood mononuclear cell apheresis in people with Peripheral Blood Mononuclear Cell, run by He Huang at 1 site in China.
Trial summary
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Blood Mononuclear Cell
- What is being tested?
- Peripheral blood mononuclear cell apheresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2020to 31 Aug 2022
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-40 years, no donation reaction in the past;
- Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;
- Blood pressure:12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg);
- Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm;
- Temperature: 36.3-37.2℃ (oral temperature);
- Generally in good condition: no damage to important organs such as heart, lung, liver and kidney; no severe or uncontrolled infection; no history of severe mental disorders;
Who cannot join
- Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease;
- Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive;
- History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3 consecutive times;
- Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC);
- Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis;
- Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.);
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- Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases);
- Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.);
- Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.);
- Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.);
- Malignancies and benign tumors affecting health;
- Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs;
- Exposure to harmful substances or radioactive substances (except for clinical radiology);
- High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners;
- Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt disease (vCJD), family history, and treatment with human and animal pituitary-derived substances (e.g. growth hormone, gonadotropin, thyrotropin, etc.). Organ transplantation recipients (including cornea, bone marrow, dura mater) may be exposed to bovine spongiform encephalopathy (BSE) and vCJD;
- Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310000
He Huang, PhD, 86-13605714822, huanghe@zju.edu.cn
About this study
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells
Read the detailed description
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
- Conditions
- Peripheral Blood Mononuclear Cell
- Being tested
- Peripheral blood mononuclear cell apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood mononuclear cell apheresisOther
Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Healthy donor | Other | Healthy donor Receives: Other: Peripheral blood mononuclear cell apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of PBMC count
UCAR-T cell
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start18 Jun 2020
- Primary completion18 Jul 2020 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Blood Mononuclear CellStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448509
- Sponsor's protocol ID
- BHCT-TCELL-04
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
- ClinicalTrials.gov ID
- NCT04448509
- Acronym / sponsor ID
- BHCT-TCELL-04
- Conditions
- Peripheral Blood Mononuclear Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 18 Jul 2020 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 26 Jun 2020 (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.
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells
Detailed description
Collect blood samples (whole blood and PBMC) from healthy donors for the development and production of UCAR-T cells
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy donor | Other | Other: Peripheral blood mononuclear cell apheresisHealthy donor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female aged 18-40 years, no donation reaction in the past;
- Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2;
- Blood pressure:12.0 Kpa (90 mmHg) ≤ systolic pressure﹤18.7 Kpa (140 mmHg) 8.0 Kpa (60 mmHg) ≤ diastolic pressure﹤12.0 Kpa (90 mmHg) Pulse pressure ≥ 4.0Kpa (30mmHg);
- Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm;
- Temperature: 36.3-37.2℃ (oral temperature);
Key exclusion criteria (16 listed)
- Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease;
- Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive;
- History of liver diseases, HBsAg positive and HCV antibody positive. 1 year after the clinical cure of hepatitis A, normal ALT test results at 1 month interval for 3 consecutive times;
- Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC);
- Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis;
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 |
|---|---|---|
| Peripheral blood mononuclear cell apheresisPeripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells | Other | Healthy donor |
Primary outcome
the number of PBMC count
Time frame: 1 years
UCAR-T cell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood mononuclear cell apheresis in people with Peripheral Blood Mononuclear Cell, run by He Huang 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 6 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 26 Jun 2020. 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.
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 He Huang, PhD (86-13605714822 ext. 86-13605714822, huanghe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of PBMC count (time frame: 1 years). 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 26 Jun 2020.