PBMCsNCT07663565
Apheresis Collection for New Drug Development and Evaluation Research
An observational study of PBMCs, run by TCRx Therapeutics Co.Ltd at 2 sites in China.
Trial summary
Peripheral Blood Mononuclear Cells (PBMC) are a mixed population of cells with a single nucleus found in peripheral blood (i.e., blood outside the bone marrow), including natural killer cells (NK), T lymphocytes (70% - 90%), and B lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- PBMCs
- What is being tested?
- None AHT
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jun 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: healthy individuals
Who may be able to join
- Aged between 18 and 40 (inclusive), male or non-pregnant female, regardless of nationality.
- Weight: Male ≥ 50kg; Female ≥ 45kg, and 19kg/m2 ≤ BMI ≤ 30kg/m2 (BMI, Body Mass Index = weight (kg) ÷ height (m)2).
- Blood pressure: Measurement results are either normal or abnormal, but without clinical significance.
- Pulse rate: Measurement of normal or abnormal pulse rate has no clinical significance.
- Temperature (ear temperature): 35.4-37.2℃. The patient's general condition is good: there is no damage to vital organs such as the heart, lungs, liver, and kidneys, no severe or uncontrolled infections, and no history of severe mental disorders.
- Clinical examination must meet the following criteria: • Hemoglobin (Hb) measurement is normal or abnormal without clinical significance • White blood cell count (WBC) measurement is normal or abnormal without clinical significance • Platelet count (PLT) measurement is normal or abnormal without clinical significance • Neutrophil count (NEU) measurement is normal or abnormal without clinical significance • Liver function test indicators <1.5ULN • Coagulation function is normal or abnormal without clinical significance • 12-lead electrocardiogram results are normal or abnormal without clinical significance • Hepatitis A virus antibody (HAV) is negative.
- Hepatitis B virus surface antigen (HBsAg) negative Hepatitis C virus antibody (HCV antibody) negative.
- Human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative. Treponema pallidum antibody test is negative. The test result for CMV IgM antibody is negative.
Who cannot join
- Previously had adverse reactions to blood donation. The following diseases are considered clinically significant by researchers: autoimmune diseases, severe endocrine and metabolic diseases, malignant tumors, neuropsychiatric diseases; Creutzfeldt-Jakob disease and those with a family history, or those who have received treatment with tissues or tissue derivatives that may have been infected with the Creutzfeldt-Jakob pathogen; chronic skin diseases, especially infectious, allergic, or inflammatory systemic skin diseases; those with allergic diseases or recurrent allergies; those who have undergone surgical operations in the past three months.
- Women who are in their menstrual period, pregnancy, less than 6 months after abortion, or less than 1 year since the end of childbirth and lactation period.
- Individuals who have recovered from an upper respiratory infection within the past week, or those who have recovered from pneumonia within the past three months.
- Individuals with urinary system infections less than 3 months old, or those experiencing an acute episode of urinary system stones.
- Equipment contaminated by blood or tissue fluid causing injury or contaminating wounds, or individuals who have undergone tattooing less than one year ago.
- Long-term uninterrupted use of hormone drugs or immunosuppressants exceeding physiological replacement doses is required, including but not limited to glucocorticoids and steroids, hydroxyurea, and immunomodulatory drugs (such as alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) in doses exceeding physiological replacement levels.
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- Those who have received whole blood and blood component transfusions within 1 year.
- Those who have received their last dose of antitoxin or immune serum within 1 year, or those who have received their last dose of hepatitis B immunoglobulin injection within 1 year.
- Individuals who have received the last dose of live attenuated vaccines such as measles, mumps, or polio vaccines within 2 weeks, or the last dose of live rubella vaccines or live attenuated Japanese encephalitis vaccines within 4 weeks.
- Individuals who have received the final immunization dose of rabies vaccine within one year after being bitten by an animal.
- Poor conditions for vascular puncture, unable to tolerate venipuncture, or history of fainting at the sight or touch of blood. Upon inquiry, individuals with a history of drug use, drug abuse, or positive drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, MDMA) within the previous 12 months prior to screening. Healthy volunteers who have participated in intervention drug clinical studies and have used study drugs within 7 days prior to screening.
- Other situations where the researcher believes participation in this study is not appropriate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Suspended
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
JingChao Liu, +86 18115621929, liujc@tcrximmune.cn
About this study
Peripheral Blood Mononuclear Cells (PBMC) are a mixed population of cells with a single nucleus found in peripheral blood (i.e., blood outside the bone marrow), including natural killer cells (NK), T lymphocytes (70% - 90%), and B lymphocytes. They can be further isolated and purified and are the main source of immune cells. This study will be conducted at our hospital, with a planned recruitment of 200 subjects. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will have their peripheral blood mononuclear cells collected via apheresis. Each subject will need to provide an apheresis sample containing approximately 8×10^9 mononuclear cells (with a sample volume of about 150 mL).
- Conditions
- PBMCs
- Being tested
- None AHT
- Keywords
- PBMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None AHTOther
No intervention measures
| Study group | Role | What they receive |
|---|---|---|
| DCX-001 | Not described Receives: Other: None AHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research on the in vitro isolation, cell expansion, and function of mononuclear cells;
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start22 Jun 2026
- Primary completion21 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PBMCsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCRx Therapeutics Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663565
- Sponsor's protocol ID
- DCX-001
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apheresis Collection for New Drug Development and Evaluation Research
- ClinicalTrials.gov ID
- NCT07663565
- Acronym / sponsor ID
- DCX-001
- Conditions
- PBMCs
- Keywords
- PBMC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- TCRx Therapeutics Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 21 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jun 2026 (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 Cells (PBMC) are a mixed population of cells with a single nucleus found in peripheral blood (i.e., blood outside the bone marrow), including natural killer cells (NK), T lymphocytes (70% - 90%), and B lymphocytes. They can be further isolated and purified and are the main source of immune cells. This study will be conducted at our hospital, with a planned recruitment of 200 subjects. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will have their peripheral blood mononuclear cells collected via apheresis. Each subject will need to provide an apheresis sample containing approximately 8×10^9 mononuclear cells (with a sample volume of about 150 mL).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCX-001 | – | Other: None AHT |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy individuals
Key inclusion criteria (8 listed)
- Aged between 18 and 40 (inclusive), male or non-pregnant female, regardless of nationality.
- Weight: Male ≥ 50kg; Female ≥ 45kg, and 19kg/m2 ≤ BMI ≤ 30kg/m2 (BMI, Body Mass Index = weight (kg) ÷ height (m)2).
- Blood pressure: Measurement results are either normal or abnormal, but without clinical significance.
- Pulse rate: Measurement of normal or abnormal pulse rate has no clinical significance.
- Temperature (ear temperature): 35.4-37.2℃. The patient's general condition is good: there is no damage to vital organs such as the heart, lungs, liver, and kidneys, no severe or uncontrolled infections, and no history of severe mental disorders.
Key exclusion criteria (12 listed)
- Previously had adverse reactions to blood donation. The following diseases are considered clinically significant by researchers: autoimmune diseases, severe endocrine and metabolic diseases, malignant tumors, neuropsychiatric diseases; Creutzfeldt-Jakob disease and those with a family history, or those who have received treatment with tissues or tissue derivatives that may have been infected with the Creutzfeldt-Jakob pathogen; chronic skin diseases, especially infectious, allergic, or inflammatory systemic skin diseases; those with allergic diseases or recurrent allergies; those who have undergone surgical operations in the past three months.
- Women who are in their menstrual period, pregnancy, less than 6 months after abortion, or less than 1 year since the end of childbirth and lactation period.
- Individuals who have recovered from an upper respiratory infection within the past week, or those who have recovered from pneumonia within the past three months.
- Individuals with urinary system infections less than 3 months old, or those experiencing an acute episode of urinary system stones.
- Equipment contaminated by blood or tissue fluid causing injury or contaminating wounds, or individuals who have undergone tattooing less than one year ago.
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 |
|---|---|---|
| None AHTNo intervention measures | Other | DCX-001 |
Primary outcome
Research on the in vitro isolation, cell expansion, and function of mononuclear cells;
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PBMCs, run by TCRx Therapeutics Co.Ltd at 2 sites 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JingChao Liu (+86 18115621929, liujc@tcrximmune.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research on the in vitro isolation, cell expansion, and function of mononuclear cells; (time frame: Baseline and 6 months). 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 Oct 2026.