Clinical trial · Interventional
Peripheral Blood Mononuclear Cell Collection Protocol for UCART Cell Tumor Immunotherapy Study
NCT04448509CI-TRIAL-00045682unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Peripheral blood mononuclear cell collection protocol for tumor immunotherapy study of UCAR-T cells
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Blood Mononuclear Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood mononuclear cell apheresis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Healthy donor
- description
- Healthy donor
- interventionNames
- Other: Peripheral blood mononuclear cell apheresis
Primary outcomes (1)
- measure
- the number of PBMC count
- timeFrame
- 1 years
- description
- UCAR-T cell
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged 18-40 years, no donation reaction in the past; 2. Weight: male ≥ 50 kg, female ≥ 45 kg, and 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2; 3. 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); 4. Pulse: 60/min to 100/min. Athletes with high endurance ≥ 50/min, with regular rhythm; 5. Temperature: 36.3-37.2℃ (oral temperature); 6. 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; Exclusion Criteria: 1. Valetudinarian, with frequent dizziness, giddiness, tinnitus, hemophobia, fear of needles, faint, and Meniere's disease; 2. Sexually transmitted diseases (STDs), leprosy, AIDS, and HIV-1, HIV-2, CMV, EBV antibody positive; 3. 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; 4. Relapsed allergic diseases, urticaria, bronchial asthma and drug allergies (Donors with simple urticaria who are not in acute attack are eligible to donate PBMC); 5. Pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis; 6. Urinary system diseases (e.g. acute and chronic nephritis, chronic urinary system infection, nephrotic syndrome, acute and chronic renal insufficiency, etc.); 7. Various hematological diseases (including anemia, leukemia, polycythemia vera and various hemorrhagic and coagulative diseases); 8. Endocrine diseases or metabolic disorders (e.g. hyperthyroidism, acromegaly, diabetes insipidus, diabetes mellitus, etc.); 9. Organic nervous system diseases or psychoses (e.g. encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, severe neurasthenia, etc.); 10. Parasitic diseases and endemic diseases (e.g. kala-azar, schistosomiasis, filariasis, hookworm disease, taeniasis, paragonimiasis, Keshan disease, Kaschin-Beck disease, etc.); 11. Malignancies and benign tumors affecting health; 12. Undergone resection of stomach, kidney, gallbladder, spleen, lung and other important organs; 13. Exposure to harmful substances or radioactive substances (except for clinical radiology); 14. High-risk groups susceptible to HIV infection, such as drug users, homosexuals and people with multiple sexual partners; 15. 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; 16. Other diseases or conditions in which donors are ineligible to donate PBMC in the opinion of physicians;
References
Publications (0)
Data not yet available
No reference posted for this study.