A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV

June 3, 2026 updated by: Biao Zhu, First Affiliated Hospital of Zhejiang University

HIV viral reservoirs represent the major barrier to curing AIDS, and effectively reducing viral reservoirs in people living with HIV through different strategies has become a research priority in the HIV field.

Ipilimumab-tovorafenib monoclonal antibody injection (Aituo combination antibody, QL1706) contains two engineered monoclonal antibodies targeting PD-1 and CTLA-4. Chidamide is the first independently developed histone deacetylase inhibitor in China. This study aims to evaluate the safety and efficacy of Aituo combination antibody combined with chidamide in people living with HIV.

This study adopts a modified "1+3+3" dose-escalation design. Initially, one participant will be enrolled at dose level 1 (DL1) for safety observation. If the treatment is well tolerated, the study will proceed to a standard 3+3 design, with sequential dose escalation to DL2 and DL3.

Three dose levels are planned: DL1, the starting dose, consists of ipilimumab-tovorafenib monoclonal antibody injection at 0.3 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL2 consists of ipilimumab-tovorafenib monoclonal antibody injection at 1 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL3 consists of ipilimumab-tovorafenib monoclonal antibody injection at 2 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks.

During dose escalation, progression to the next dose level or discontinuation of escalation will be determined according to the occurrence of dose-limiting toxicities (DLTs). The DLT observation window is 28 days after the first dose. Participants evaluable for DLT are those who complete the observation window or experience a DLT. After completion of dose escalation, the maximum tolerated dose (MTD) will be determined based on safety and tolerability. If the MTD is not reached, DL3 will be selected as the dose for subsequent study.

After determination of the MTD or the subsequent study dose, an additional 11 participants will be enrolled at that dose level to further evaluate safety, tolerability, and preliminary efficacy. The maximum total sample size of the study will be 29 participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged 18-65 years.
  2. Confirmed HIV infection by both initial screening assay and Western blot (WB) confirmatory test.
  3. Receiving a stable ART regimen for at least 6 months.
  4. Viral load below the lower limit of detection.
  5. CD4+ T-cell count >200 cells/mm³.
  6. Voluntarily signed the informed consent form and able to comply with regular follow-up visits, specimen collection, and monitoring/treatment of study-related adverse events.
  7. Use effective contraception from 4 weeks prior to study initiation until 4 weeks after study completion.

Exclusion Criteria:

  1. Pregnant or breastfeeding women, or women planning to become pregnant during the study observation period.
  2. Subjects with poor treatment adherence.
  3. Receipt of immunosuppressants, other immunomodulatory agents, or cytotoxic drugs within 6 months prior to screening.
  4. Presence of severe underlying cardiac, cerebral, hepatic, renal, or other systemic diseases; neutrophil count <1000/mm³; platelet count <75,000/mm³; allergy to the investigational drug; or other contraindications to treatment.
  5. Presence of progressive (or active) malignancy, including but not limited to advanced, metastatic, or unresectable solid tumors or hematologic malignancies.
  6. Unwillingness to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ibalizumab Combined with Chidamide
Drug: Ibalizumab Combined with Chidamide
Three dose levels are planned: DL1, the starting dose, consists of ipilimumab-tovorafenib monoclonal antibody injection at 0.3 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL2 consists of ipilimumab-tovorafenib monoclonal antibody injection at 1 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL3 consists of ipilimumab-tovorafenib monoclonal antibody injection at 2 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and proportion of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame: A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).
Safety will be assessed by the incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events, including adverse events, serious adverse events, laboratory abnormalities, vital sign abnormalities, and physical examination findings. Adverse events will be graded according to CTCAE v5.0.
A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).
Number and proportion of participants who discontinue or interrupt study treatment due to adverse events
Time Frame: A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).
Tolerability will be assessed by the number and proportion of participants who discontinue, interrupt, or modify study treatment because of adverse events or clinically significant laboratory abnormalities.
A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in HIV reservoir size as measured by total HIV DNA and CA HIV RNA
Time Frame: A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).
Exploratory efficacy will be assessed by the change from baseline in HIV reservoir size, measured by total HIV DNA and CA HIV RNA in peripheral blood mononuclear cells at scheduled study visits.
A total of 8 study visits are planned, including Visit 1 (Week -2), Visit 2 (Week 0), Visit 3 (Week 4 ± 1 day), Visit 4 (Week 8 ± 1 day), Visit 5 (Week 12 ± 1 day), Visit 6 (Week 16 ± 1 day), Visit 7 (Week 20 ± 1 day), and Visit 8 (Week 24 ± 1 day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCIT-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

  1. Participant Privacy and Confidentiality:

    Although data would be de-identified prior to sharing, the IPD encompass detailed clinical, virologic, and immunologic parameters. Given the specific sensitivities associated with the HIV-infected population and the nature of the medical information, a residual risk of re-identification through the triangulation of indirect identifiers persists. Public sharing of IPD may therefore contravene data protection regulations and the privacy assurances stipulated in the participant informed consent documentation.

  2. Limitations of Informed Consent Scope:

The informed consent form executed for this study does not explicitly authorize the disclosure of participant-level raw data to third parties or its deposition in public data repositories. The investigators are bound by legal and ethical obligations to utilize the data solely within the parameters approved in the study protocol and the corresponding informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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