Acquired immunodeficiency syndrome, hematologic malignancies
Conditions
Interventions
Intervention Group:Allogeneic hematopoietic stem cell with stable expression of 7shRNA transplantation
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. 18 (inclusive)-60 (inclusive) years old, both males and females. 2. Body weight = 40kg. 3. Being diagnosed as HIV positive according to the "Guidelines for Diagnosis and Treatment of AIDS in China" (2021 Edition). 4. Taking antiviral drugs and the viral load of HIV is below the detection limit. 5. CD4+ T cell count > 200 cells/µl. 6. Patients with hematological malignancies with poor prognosis treated with drugs alone, including but not limited to: a. Acute myeloid or lymphocytic leukemia in primary or secondary complete remission. b. Myelodysplastic syndrome. c. Chronic myelomonocytic leukemia. 7. Meeting the indications for allogeneic hematopoietic stem cell transplantation after clinical evaluation. 8. HLA-matched or haploidentical donor is available. 9. The organ function is relatively normal, which can be determined by the following methods: a. Cardiac function: Echocardiography shows left ventricular ejection fraction = 50% at rest. Patients with known heart disease must have a functional status no worse than American Heart Association Class I (Class I is defined as a patient with heart disease, but not resulting in restriction of physical activity, ordinary physical activity does not cause Palpitations, shortness of breath, or angina). b. Liver function: I. Total bilirubin 70 mL/min. d. Lung function: predicted value of DLCO, FEV1 or FEV1/FVC = 60%. 10. Life expectancy would be at least 1 year. 11. Willing and able to provide written informed consent. 12. Willing and able to abide by the research procedures and requirements, and be able to follow up as planned.
Exclusion criteria
Exclusion criteria: 1. Karnofsky/Lansky score <60%. 2. There are uncontrolled active opportunistic infections related to HIV infection, including fungal infections, sepsis, active tuberculosis, Treponema pallidum, weightlessness, severe diarrhea, active opportunistic infections of the central nervous system; or active hepatitis B , hepatitis C, and other viral infections. 3. HAART treatment failure (including at least one NRTI resistance, one NNRTI resistance and two PI2 resistance) and/or CD4+ T cell count < 200/µl. 4. AIDS-related syndromes or symptoms that have a significant risk of transplant-related mortality as determined by the principal investigator. 5. Any malignancies other than hematological malignancies. 6. Pregnant or lactating women. 7. Participated in other trials (except traditional Chinese medicine) within the past three months. 8. Previously received allogeneic hematopoietic stem cell transplantation. 9. Any HIV-related encephalitis, any type of mental confusion or epilepsy within the past 12 months. 10. The researchers believe that they have a low possibility of enrollment (such as frailty, poor compliance, etc.) or any other factors that are not suitable for entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE and SAE;Allogeneic CD34+ cells stably expressing 7shRNA;GVHD;Time to successful neutrophil engraftment;Time to successful platelet engraftment;Site of lentiviral integration;Vector-derived RCL; | — |
Secondary
| Measure | Time frame |
|---|---|
| TRM;Recurrence rate after transplantation;OS;Viral load of HIV;CD4+ T cell count;Ratio of CD4+/CD8+ T cell; VCN of 7shRNA;Proportion of subjects achieving discontinuation of HAART;Number of people with disease load below the detection limit within 6 months after discontinuing HAART and the duration of discontinuing HAART; | — |
Countries
China
Contacts
Public ContactSizhou Feng
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed