Allogeneic Adoptive Immune Therapy for Advanced AIDS Patients
NCT ID: NCT04098770
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2019-10-11
2024-12-30
Brief Summary
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Detailed Description
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In pre-cARTera, HLA-matched lymphocytes or stem cell transplantation had been exploratively used in AIDS patients. However, this kind of therapy failed for immunological reconstitution due to the lack of antiviral therapy to suppress HIV-1 replication at that time. With the advent of cART, allogeneic HLA-matched or mismatched lymphocytes or stem cell transplantations were mainly used for AIDS patients with hematopoietic malignancies, the Berlin and London patients were the cured pateints. However, allogeneic transplantation can not be used outside the setting of hematopoietic malignancies. In addition, the high frequency of GVHD (Graft-versus-host disease) owning to a transient or long-lasting engraftment is inevitable.
Until now, there has been no report of effective immune therapy for late-stage AIDS patients with acquired immunodeficiency and severe opportunistic infections (OIs). The urgent challenge is how to efficiently restore the host holistic immunity in AIDS patients at late stage.
The investigators have recently developed a mismatched allogeneic adoptive immune therapy (AAIT) protocol in combination with cART, and found that the treatment was safety and tolerability in a phase I study. The purpose of this study is to further investigate the efficacy of allogeneic adoptive immune therapy (AAIT) for advanced AIDS patients. 120 patients received i.v. transfusion one round (2-3 times) of 1.0-3.0\*10E8 cells/kg of MNSs as the treated group, all of these patients received the conventional cART treatment. In addition, the equal 120 patients received cART were used as control. The side effects, CD4 T cell numbers, HIV viral load, clinical symptoms improvement, control of opportunistic infections, AIDS-related events and non-AIDS related events will be evaluated during the 96-week follow up.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional treatment plus Allogeneic Adoptive Immune Therapy
Participants will receive conventional treatment (anti-opportunistic infections, cART and other treatments) plus a dose (2-3 times) of Allogeneic Adoptive Immune Therapy
Allogeneic Adoptive Immune Therapy
A dose (2-3 times) of AAIT was added on conventional treatment for advanced AIDS patients
Conventional treatment
Without Allogeneic Adoptive Immune Therapy but conventional treatment (anti-opportunistic infections , cART and other treatments) should be received
No interventions assigned to this group
Interventions
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Allogeneic Adoptive Immune Therapy
A dose (2-3 times) of AAIT was added on conventional treatment for advanced AIDS patients
Eligibility Criteria
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Inclusion Criteria
2. Advanced AIDS patients with AIDS-related events
3. Advanced patients with CD4 count less than or equal to 200 cells/uL, including end-stage patients with CD4 count less than or equal to 50 cells/uL before entry and at screening
4. Sign informed consent, do not participate in other clinical trails during the period
Exclusion Criteria
2. Combined with other serious organic diseases while didn't related with AIDS
3. HIV-2 infection
4. Allergic to blood products
5. Under long term immunosuppressive therapy
6. Combined with malignant tumors
7. Drug addicts within half-one year before the test
8. Poor compliance to antiviral therapy; take part in other clinical trials at present
18 Years
65 Years
ALL
No
Sponsors
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The 6th people's Hospital of Xinjiang province
UNKNOWN
The 4th people's hospital of Nanning City
UNKNOWN
The 3th people's hospital of Shenzhen City
UNKNOWN
Shanghai Public Health Clinical Center
OTHER_GOV
Yunnan Provincial Hospital of Infectious Diseases
UNKNOWN
Beijing 302 Hospital
OTHER
Responsible Party
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Fu-Sheng Wang
Head of Treatment and Research Center for Infectious Diseases, Principle Investigator, Clinical Professor
Principal Investigators
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Fu-Sheng Wang, MD
Role: STUDY_DIRECTOR
Beijing 302 Hospital
Locations
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Beijing 302 Hospital of China
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Kuritzkes DR. Hematopoietic stem cell transplantation for HIV cure. J Clin Invest. 2016 Feb;126(2):432-7. doi: 10.1172/JCI80563. Epub 2016 Jan 5.
Hutter G, Nowak D, Mossner M, Ganepola S, Mussig A, Allers K, Schneider T, Hofmann J, Kucherer C, Blau O, Blau IW, Hofmann WK, Thiel E. Long-term control of HIV by CCR5 Delta32/Delta32 stem-cell transplantation. N Engl J Med. 2009 Feb 12;360(7):692-8. doi: 10.1056/NEJMoa0802905.
Krishnan A. Stem cell transplantation in HIV-infected patients. Curr Opin HIV AIDS. 2009 Jan;4(1):11-5. doi: 10.1097/COH.0b013e32831a6fc9.
Davis KC, Hayward A, Ozturk G, Kohler PF. Lymphocyte transfusion in case of acquired immunodeficiency syndrome. Lancet. 1983 Mar 12;1(8324):599-600. doi: 10.1016/s0140-6736(83)92855-6. No abstract available.
Lane HC, Masur H, Longo DL, Klein HG, Rook AH, Quinnan GV Jr, Steis RG, Macher A, Whalen G, Edgar LC, et al. Partial immune reconstitution in a patient with the acquired immunodeficiency syndrome. N Engl J Med. 1984 Oct 25;311(17):1099-103. doi: 10.1056/NEJM198410253111706. No abstract available.
Lane HC, Zunich KM, Wilson W, Cefali F, Easter M, Kovacs JA, Masur H, Leitman SF, Klein HG, Steis RG, et al. Syngeneic bone marrow transplantation and adoptive transfer of peripheral blood lymphocytes combined with zidovudine in human immunodeficiency virus (HIV) infection. Ann Intern Med. 1990 Oct 1;113(7):512-9. doi: 10.7326/0003-4819-113-7-512.
Yang T, Xie Z, Xu Z, Tu B, Lu H, Huang H, Huang L, Zhang C, Gao L, Jin L, Ma P, Zou J, Liu L, Zhen C, Zhou C, Meng S, Li YY, Song JW, Yang S, Ai HS, Jiao Y, Shi M, Xu R, Wang FS. HLA-mismatched allogeneic adoptive immune therapy in patients with severely immunosuppressed AIDS: a multicenter, open-label, controlled, phase 2a study. Emerg Microbes Infect. 2024 Dec;13(1):2364744. doi: 10.1080/22221751.2024.2364744. Epub 2024 Jun 27.
Other Identifiers
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302-2019-05
Identifier Type: -
Identifier Source: org_study_id
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