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Clinical studies of multivirus-specific T cells for viral infection in immunocompromised patients

Clinical studies of multivirus-specific T cells for viral infection in immunocompromised patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060163
Enrollment
Unknown
Registered
2022-05-21
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

viral infection in immunocompromised patients

Interventions

Group A:Autogenous multivirus specific CTL cells cultured with IL-7 (IL-7/15/21) system
Group B:Autologous polyvirus-specific CTL cells were cultured with IL-2 (IL-2/12) system

Sponsors

Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients infected with immunodeficiency virus include patients infected with CMB, EBV, Adv, etc., including patients receiving immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation, solid organ transplantation, kidney disease, rheumatism disease and blood system disease. Patients were preferentially enrolled after allogeneic hematopoietic stem cell transplantation. 2. The expected survival time is 6 weeks or longer. 3. Patients who had previously received radiation therapy and had pulse oxygen saturation above 95% while breathing air. 4. Karlansky/Lansky score is greater than or equal to 50. 5. Bilirubin is less than or equal to 2x upper limit of normal, AST is less than 3x upper limit of normal, and hemoglobin is > 80g/L. 6. Creatinine below 2x upper limit of normal for age. 7. Patients should stop receiving other investigational therapy for at least 1 month before entering the study. 8. Patients should stop receiving traditional therapy, including rituximab, for at least 1 week before entering the study. 9. Patient has been fully informed of the risks and benefits of participating in the study and can sign the informed consent by patient and/or parent/guardian.

Exclusion criteria

Exclusion criteria: 1. Antithymocyte globulin (ATG) infusion was used within 4 weeks for transplant recipients; 2. Grade II or above acute graft-versus-host disease within 1 week of infusion; 3. Prednisone > 1 mg/kg body weight or equivalent for recipients; 4. Patients enrolled in other clinical trials within 3 months; 5. Previous history of malignant tumor; 6. For pregnant or lactating patients, serum or urine pregnancy test was performed before transfusion, and the test result was positive; 7. Other conditions deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Serological detection of virus;

Countries

China

Contacts

Public ContactZhou Li

Anhui Provincial Hospital

zhouli-324@1603.com+86 17756071226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026