HIV InfectionsPhase 2NCT05129189
Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide in HIV-infected Patients With Antiviral Suppression
A Phase 2 study testing ASC22 group in people with HIV Infections, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
In HIV-infected patients, enhanced PD-1 expression of T cells correlates with T cell depletion, as evidenced by reduced virus-specific proliferative capacity and decreased cytokine expression.Targeting PD-L1 drugs to block PD-1/PD-L1 signaling may promote the secretion of antiviral cytokines and achieve HIV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- ASC22 group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2022to 31 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People diagnosed with HIV infection.
- Age ≥18 years.
- In good general health with a body mass index ≥18.0 to <35.0 kg/m2.
- Able to comply with the time requirements for study visits and assessments.
- Currently on cART for at least 24 months with two consecutive plasma HIV-1 RNA < 50 copies/ml at least 12 months apart.
- CD4+ T-cell count ≥ 250 cells/µl (including borderline values) and CD4/CD8 < 0.9 during the screening period.
- Agree to adhere to contraception during participation in the project and for 6 months after completion of the trial.
- Willing to sign the informed consent form.
Who cannot join
- Subjects who have had any serious acute illness within 8 weeks.
- Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic therapy.
- Pre-treatment/exposure to any other immune checkpoint inhibitors [e.g., anti-programmed cell death protein 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.].
- The patient has been treated with
- Received previous treatment with other anti-submarine drugs within 30 days prior to enrollment.
- Received radiotherapy or chemotherapy 30 days prior to screening.
Show all 34Show fewer
- Received immunosuppressive therapy 60 days prior to screening.
- Treatment with immunomodulators (e.g., interleukins, interferons), hydroxyurea, or phosphonates 60 days prior to screening.
- HIV vaccine or systemic cytotoxic chemotherapy 60 days prior to screening.
- Prior immunoglobulin (IgG) therapy.
- Previous blood transfusion or cell growth factor therapy 90 days prior to screening.
- Use of rifampicin, rifabutin, etc. at the time of screening or during the planned treatment phase.
- Laboratory tests meet the following criteria.
- absolute neutrophil count (ANC) <1.50×109/L; hemoglobin (Hb) <105 g/L (male) or <95 g/L (female); platelets <75×10^9/μ L; international normalized ratio (INR) >1× upper limit of normal (ULN).
- Serum alanine aminotransferase (SGPT/ALT) >1.5× upper limit of normal (ULN), serum aspartate aminotransferase (SGOT/AST) >1.5× upper limit of normal (ULN), total bilirubin, direct bilirubin >1.5× upper limit of normal (ULN), serum creatinine >1.5× upper limit of normal (ULN) × upper limit of normal value (ULN).
- Five abnormal thyroid functions with clinical significance: tests include triiodothyronine (T3), tetraiodothyronine (T4), free triiodothyronine (FT3), free tetraiodothyronine (FT3), free tetraiodothyronine (FT4), and thyroid stimulating hormone (TSH).
- Abnormal and clinically significant adrenaline tests, which must include at least ACTH and cortisol. Abnormal and clinically significant blood glucose and glycated hemoglobin.
- Abnormal and clinically significant twelve-lead ECG at the time of enrollment.
- Subjects with interstitial changes on chest CT at the time of enrollment.
- Subjects with severe cardiac disease, symptomatic or asymptomatic arrhythmias.
- Patients with co-infection with HBV, HCV, syphilis, etc., patients with diabetes mellitus, and patients with other liver diseases.
- Subjects with a history of active or suspected malignancy or malignant disease (except basal cell skin cancer or in situ cervical cancer) within five years.
- Subjects with a history of tuberculosis or active tuberculosis.
- Subjects with psychiatric or substance abuse disorders known to interfere with study requirements.
- Subjects who have received immunomodulation or immunosuppression within 24 weeks prior to the first dose of study drug (including any dose of IV/oral [PO] steroids, but excluding steroids by inhalation, topical, or by local injection) within 24 weeks prior to the first dose of the study drug.
- Pregnant and lactating women, or men and women who intend to conceive a child during the study period.
- Psychiatric patients or those whose substance abuse interferes with the conduct of the trial.
- Histone deacetylase inhibitors, such as valproate, butyrate, and phenylbutyrate, but may be enrolled after a 28-day elution period.
- Patients with severe cardiac insufficiency [New York Heart Association (NYHA) Cardiac Insufficiency Classification Class IV].
- Any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, within 6 months prior to enrollment; normatively treated uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); cardiomyopathy
- Patients with significant QT/QTC interval during the screening period (Fridericia formula.
- Patients with a significant prolongation of the QT/QTC interval (Fridericia formula: QTcF=QT/RR0.33) during the screening period (e.g., repeated measurements showing a QTc interval >450 ms, or another risk of torsional ventricular tachycardia [TdP] [e.g., heart failure, hypokalemia, familial long QT syndrome]) or combination of drugs that may cause prolongation of the QT/QTc interval.
- Known allergy or anti-drug antibodies to drugs or excipients used in this trial.
- Those who are judged by the investigator to be unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Jun Chen, M.D, +86-021-37990333 ext. 3222, qtchenjun@163.com
About this study
Official title: Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide
In HIV-infected patients, enhanced PD-1 expression of T cells correlates with T cell depletion, as evidenced by reduced virus-specific proliferative capacity and decreased cytokine expression.Targeting PD-L1 drugs to block PD-1/PD-L1 signaling may promote the secretion of antiviral cytokines and achieve HIV clearance.The mechanism of action of ASC22 is to competitively block the binding of PD-1 molecules to PD-L1 through its antigen-binding region with a high affinity for hPD-L1, thereby stimulating an innate or adaptive immune response with sustained T-cell activation.This study was conducted to evaluate whether ASC22 combined with chidamide in HIV-infected patients with antiviral suppression could shrink the viral reservoir.
- Conditions
- HIV Infections
- Being tested
- ASC22 group
- Keywords
- Functional cure of HIV， ASC22，PD-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC22 groupDrug
The trial group received ASC22 1mg/kg hypodermic injection Q4W and Chidamide 10mg PO BIW.
| Study group | Role | What they receive |
|---|---|---|
| ASC22 group | Experimental | ASC22 1mg/kg hypodermic injection Q4W+Chidamide 10mg PO BIW Receives: Drug: ASC22 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 DNA levels
Change in HIV-1 DNA levels from baseline at each cycle of treatment
Measured: 52 weeks
Secondary outcomes (3)
CD4+ T-cell count, CD4+ T-cell percentage, CD8+ T-cell count, CD4+/CD8+ ratio
Changes in CD4+ T-cell count, CD4+ T-cell percentage, CD8+ T-cell count, CD4+/CD8+ ratio, and change from baseline at each cycle of treatment
Measured: 52 weeks
HIV gag-specific CD8+ T ratio
Change from baseline in HIV gag-specific CD8+ T ratio at each cycle of treatment
Measured: 52 weeks
HIV-1 RNA
Change in HIV-1 RNA from baseline at each cycle of treatment
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start29 Jun 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Chen, MD, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129189
- Sponsor's protocol ID
- ASC22
- Status last verified
- Sep 2022
- First submitted
- 15 Nov 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu L, Zheng Z, Xun J, Liu L, Wang J, Zhang X, Shao Y, Shen Y, Zhang R, Zhang M, Sun M, Qi T, Wang Z, Xu S, Song W, Tang Y, Zhao B, Song Z, Routy JP, Lu H, Chen J. Anti-PD-L1 antibody ASC22 in combination with a histone deacetylase inhibitor chidamide as a "shock and kill" strategy for ART-free virological control: a phase II single-arm study. Signal Transduct Target Ther. 2024 Sep 9;9(1):231. doi: 10.1038/s41392-024-01943-9.
PubMed 39245675
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Cure Study of Anti-PD-L1 Antibody ASC22 in Combination With Chidamide
- ClinicalTrials.gov ID
- NCT05129189
- Acronym / sponsor ID
- ASC22
- Conditions
- HIV Infections
- Keywords
- Functional cure of HIV， ASC22，PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In HIV-infected patients, enhanced PD-1 expression of T cells correlates with T cell depletion, as evidenced by reduced virus-specific proliferative capacity and decreased cytokine expression.Targeting PD-L1 drugs to block PD-1/PD-L1 signaling may promote the secretion of antiviral cytokines and achieve HIV clearance.The mechanism of action of ASC22 is to competitively block the binding of PD-1 molecules to PD-L1 through its antigen-binding region with a high affinity for hPD-L1, thereby stimulating an innate or adaptive immune response with sustained T-cell activation.This study was conducted to evaluate whether ASC22 combined with chidamide in HIV-infected patients with antiviral suppression could shrink the viral reservoir.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASC22 group | Experimental | Drug: ASC22 groupASC22 1mg/kg hypodermic injection Q4W+Chidamide 10mg PO BIW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People diagnosed with HIV infection.
- Age ≥18 years.
- In good general health with a body mass index ≥18.0 to <35.0 kg/m2.
- Able to comply with the time requirements for study visits and assessments.
- Currently on cART for at least 24 months with two consecutive plasma HIV-1 RNA < 50 copies/ml at least 12 months apart.
Key exclusion criteria (34 listed)
- Subjects who have had any serious acute illness within 8 weeks.
- Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic therapy.
- Pre-treatment/exposure to any other immune checkpoint inhibitors [e.g., anti-programmed cell death protein 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.].
- The patient has been treated with
- Laboratory tests meet the following criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC22 groupThe trial group received ASC22 1mg/kg hypodermic injection Q4W and Chidamide 10mg PO BIW. | Drug | ASC22 group |
Primary outcome
HIV-1 DNA levels
Time frame: 52 weeks
Change in HIV-1 DNA levels from baseline at each cycle of treatment
3 secondary outcomes
CD4+ T-cell count, CD4+ T-cell percentage, CD8+ T-cell count, CD4+/CD8+ ratio
Time frame: 52 weeks
HIV gag-specific CD8+ T ratio
Time frame: 52 weeks
HIV-1 RNA
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 39245675Wu L, Zheng Z, Xun J, Liu L, Wang J, Zhang X, Shao Y, Shen Y, Zhang R, Zhang M, Sun M, Qi T, Wang Z, Xu S, Song W, Tang Y, Zhao B, Song Z, Routy JP, Lu H, Chen J. Anti-PD-L1 antibody ASC22 in combination with a histone deacetylase inhibitor chidamide as a "shock and kill" strategy for ART-free virological control: a phase II single-arm study. Signal Transduct Target Ther. 2024 Sep 9;9(1):231. doi: 10.1038/s41392-024-01943-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC22 group in people with HIV Infections, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D (+86-21-37990333 ext. 3222, qtchenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 DNA levels (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.