Status:
UNKNOWN
Third-Generation CAR-T-cell Therapy in Individuals With HIV-1 Infection
Lead Sponsor:
Beijing 302 Hospital
Collaborating Sponsors:
Tsinghua University
Conditions:
HIV-1
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To evaluate the safety of autologous CAR-T-cell therapy in individuals lived with HIV-1 infection, CAR T cells are infused after ex vivo expansion and transduction with lentiviral vectors encoding a b...
Detailed Description
This study is a prospective, single-center, single-arm, open-label and phase I clinical trial. Subjects with CD4+T cell counts greater than 350/μl and viral loads of \<50 copies/ml over 1 year by anti...
Eligibility Criteria
Inclusion
- Aged 18 to 70 years
- HIV-1 infection by confirmed test;
- Receiving antiviral treatment ≥ 1 years;
- Current CD4+ T cell count \> 350 cells/μl;
- HIV-1 RNA levels of \< 50 copies/ml for at least a year;
- Patients who agrees to use two effective methods of contraception to avoid pregnancy during the study period.
- Patients who sign the informed consent form prior to inclusion in the study.
Exclusion
- Patients with concomitant HAV, HBV, HCV, HDV, HEV, EBV, CMV or syphilis infection;
- A history of AIDS-related opportunistic infections and tumors within 1 year prior to enrollment;
- A History of corticosteroids or immunosuppressive drugs for autoimmune diseases by physicians within the last 2 years;
- Participants with clinically significant laboratory abnormalities as follows:
- Hemoglobin ≤ 10 gm/dl (female), \<11g/dl (male)
- Absolute neutrophil count ≤ 1×10\^9/L
- Platelet count ≤100×10\^9/L
- Alanine aminotransferase (ALT)≥ 2.5 x ULN
- Aspartate aminotransferase (AST) ≥ 2.5 x ULN
- Total bilirubin \> 1.5 ULN
- Serum creatinine \>110 μmol/L
- International normalized ratio (INR) \>1.5 or activated partial thromboplastin time (APTT) \>45 s
- Patients with severe psychiatric illness, drugs or alcohol abuse;
- A woman who is in pregnancy or lactation;
- A history of central nervous system disease, such as cerebral hemorrhage, dementia, epilepsy and autoimmune diseases;
- Patients with a non-AIDS-related serious underlying disease;
- Patients who participate in another clinical study currently which may affect the results of this study.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04863066
Start Date
May 1 2021
End Date
October 1 2022
Last Update
April 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
302 Hospital
Beijing, China, 100039