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An single-center, open-label and case control clinical study to evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection

An single-center, open-label and case control clinical study to evaluate safety and efficacy of Anti-gp120 CAR-T cells plus HAART treatment for untreated patients with HIV-1 infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17013068
Enrollment
Unknown
Registered
2017-10-21
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-10-23

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

Conditions

HIV-1 infection disease

Interventions

A:CAR-T Cells treatment
C:Non- myeloablative pre-treated and Car-T cells treatment

Sponsors

Jinyintan Hospital of WuHan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-65 years; 2. Confirmed HIV-1 infection; 3. HIV viral load between 1x104 and 1x106cp/mL; 4. CD4+T cell count>200/ul; 5. Multiple organ function assessment: ALT /AST80ml/min; SPO2>=95%; LVEF>40%; blood routine shows WBCPLTHb are normal; head CT and EEG are normal 6. have the ability to understand the study and C34Voluntary participation in the clinical trials and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. haven't received HIV antiretroviral therapy; 2. Within 90 days of the screening, received the treatment of immunomodulatory, cytokines or growth stimulating factors, such as systemic corticosteroids, Systemic corticosteroids, cyclosporin, azathioprine, methotrexate, anti CD25 antibody, IFN, IL-2; coumarin, warfarin or other anticoagulants like coumarin cerivatives; 3. Within 90 days befor enrolled, reveived the treatment of venous blood products, immunoglobulin, hemopoietic growth factor; 4. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 5. Pregnancy and nursing females; 6. With malignant tumor,autoimmune diseases; With uncontrolled diabetes,hypertension; With cardiac,lung, liver, renal insufficiency, or with other serious organic disease; 7. With systemic active infections that need treatments, including syphilis, active tuberculosis, clinically active hepatitis A, B and C; 8. History of mental disorders; 9. Participation or be enrolling in an investigational research study within 3 months before enrolled; 10. Alcohlim or drug abuse; 11. Received concomitant medication prohibited for HAART treatment; 12. Allergic to any cytokines or antibodies; 13. Other situations we think improper for the research.

Design outcomes

Primary

MeasureTime frame
Adverse effects rate;—

Countries

China

Contacts

Public ContactTongcun Zhang/Dingyu Zhang

YunGu Biomedical Technology Co., Ltd. /Jinyintan Hospital of WuHan

zhangtongcun@wust.edu.cn+86 027-87570668/027-85509836

Outcome results

None listed

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