TMB-365 + TMB-380 for HIV

No longer recruiting at 8 trial locations

Overseen By Edwin DeJesus, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: TaiMed Biologics Inc.

Must be taking: cART

Must not be taking: Cabotegravir, Rilpivirine

Disqualifiers: Pregnancy, Schizophrenia, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatments, TMB-365 and TMB-380, for individuals with HIV who are already on medication that controls the virus. The goal is to determine if these treatments, which block the virus from entering cells, are safe and how they behave in the body. Participants will receive infusions of these treatments, and researchers will monitor their health and the treatments' ability to maintain virus suppression without their usual oral medication for a period. Individuals with HIV who have been on stable treatment for at least six months and have no detectable virus levels might be suitable for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatments work in people and measure their effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

Participants will need to stop their current oral cART (combination antiretroviral therapy) for 24 weeks as part of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using TMB-365 and TMB-380 together is safe for people with HIV. One study found that a single dose of up to 4800 mg of each treatment was well-tolerated, with no serious side effects. The study also discovered that these treatments remain in the body for a long time, suggesting they might only need administration every 8 weeks.

These results are encouraging for those considering participation in a trial with these medications. While the study continues to explore safety further, the initial findings suggest that TMB-365 and TMB-380 are safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TMB-365 and TMB-380 for HIV because these are monoclonal antibodies designed to target the virus in a new way. Unlike standard antiretroviral therapies (ART) that require daily oral doses and work by preventing the virus from replicating, these antibodies are administered through infusions every 8 weeks, potentially reducing the treatment burden for patients. This novel approach not only aims to maintain antiviral activity but also offers a promising strategy to manage HIV with fewer doses, which could lead to better adherence and improved quality of life for those living with HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that TMB-365 and TMB-380 are promising treatments for HIV. These monoclonal antibodies target specific parts of the virus. TMB-365 attaches to the CD4 receptor, while TMB-380 targets the HIV virus itself. Early results suggest these antibodies can prevent the virus from entering cells, which is crucial for stopping its spread. In this trial, participants in Core Group 1 will receive 4800 mg infusions of each antibody every 8 weeks, while those in the Sentinel Groups will receive a single infusion of varying doses. Earlier studies demonstrated that single doses of these antibodies are safe and remain active in the body for an extended period. This could reduce the number of treatments needed, making it easier for people to stay healthy. ^{1 3 4 5 6}

Who Is on the Research Team?

Jay Lalezari, MD

Principal Investigator

Quest Clinical Research

Are You a Good Fit for This Trial?

Adults aged 18-60 with asymptomatic HIV-1, on stable cART for at least 6 months without interruption, and have undetectable viral loads. They must have a CD4+ T cell count over 350 cells/mm3 and meet certain lab value criteria. Women of childbearing potential must agree to use contraception and undergo pregnancy tests.

Inclusion Criteria

Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study

I agree to use birth control and undergo pregnancy tests if I can still have children.

In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.

Exclusion Criteria

I have not received monoclonal antibodies for HIV except as a Sentinel subject.

Any chronic or acute medical condition, including chronic Hepatits B infection, chronic Hepatitis C infection with viremia, and drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug

I haven't taken immune system drugs, HIV vaccines, chemotherapy, or experimental treatments in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sentinel Group Treatment

Participants receive a single IV dose of TMB-365 and TMB-380 while continuing cART, followed by safety and pharmacokinetics assessment

12 weeks

Multiple visits for infusion and monitoring

Core Group Treatment

Participants receive multiple IV doses of TMB-365 and TMB-380 as a stand-alone maintenance regimen for 24 weeks

24 weeks

Infusions every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Follow-up visits post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• TMB-365/TMB-380

Trial Overview The trial is testing the safety and how the body processes different doses of two monoclonal antibodies, TMB-365 and TMB-380 (VRC-07-523LS), in individuals with suppressed HIV who are on cART. The goal is to find optimal dosing for these drugs as maintenance therapy without oral cART for 24 weeks.

How Is the Trial Designed?

Group I: Sentinel Group 3 Experimental Treatment 1 Intervention

10 HIV-1 infected subjects will receive one infusion of 4800 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group II: Sentinel Group 2 Experimental Treatment 1 Intervention

10 HIV-1 infected subjects will receive one infusion of 3200 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group III: Sentinel Group 1 Experimental Treatment 1 Intervention

10 HIV-1 infected subjects will receive one infusion of 2400 mg of each antibody, TMB-365 and TMB-380 and be followed for safety and pharmacokinetics. Oral suppressive cART will be continued throughout the course of the study participation.

Group IV: Core Group 1 Experimental Treatment 1 Intervention

20 HIV-1 infected subjects will receive 4800 mg infusions of each antibody, TMB-365 and TMB-380 every 8 weeks and be followed for safety, pharmacokinetics, and ability to maintain antiviral activity. Oral suppressive cART will be discontinued for 24 weeks then resumed at week 24 with follow-up at week 28.

Who Is Running the Clinical Trial?

TaiMed Biologics Inc.

Lead Sponsor

Trials

9

Recruited

390+

Published Research Related to This Trial

In a study of 307 antiretroviral-experienced HIV-1-infected individuals, the 1-year probability of virological failure on an ABC + TDF regimen was 34%, with higher failure rates linked to the absence of a potent cART regimen and a greater number of prior treatments.

For patients starting therapy with a viral load ≤400 copies/ml, the virological failure rate was lower at 17%, indicating that initial viral load and treatment history significantly influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of antiretroviral regimens containing abacavir with tenofovir in treatment-experienced patients: predictors of virological response and drug resistance evolution in a multi-cohort study. Di Giambenedetto, S., Torti, C., Prosperi, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05275998

TMB-365 and TMB-380 in Suppressed HIV-1 Infected ... This study is designed to test various doses of the combination of the antibodies for safety and pharmacokinetics in suppressed subjects on cART. Once dosing is ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07215468

HIV-1 Virologic Suppression With TMB-365 and TMB-380 ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial ...

3. taimedbiologics.com taimedbiologics.com/article_d.php?lang=en&tb=5&id=2622

TaiMed Biologics Announces its Long-Acting TMB-365/380 ... This clinical study aims to evaluate the safety, efficacy, and pharmacokinetics profile of the long-acting TMB-365/TMB-380 combination as a ...

4. croiconference.org croiconference.org/wp-content/uploads/sites/2/posters/2025/701-2025.pdf

A 24-Week Phase II Maintenance Study of TMB-365/ ... This study was to evaluate the safety, efficacy, and PK of the TMB-. 365 and TMB-380 combination given as a single IV infusion in people with suppressed HIV.

5. natap.org natap.org/2024/CROI/croi_61.htm

A DOSE ESCALATION STUDY OF SAFETY & PK OF TMB- ... A single infusion of TMB-365 and TMB-380 in combination up to 4800 mg each is safe. Prolonged PK duration was observed for both TMB-365 and TMB- ...

6. croiconference.org croiconference.org/wp-content/uploads/sites/2/posters/2024/640.pdf

a dose escalation study of safety & pk of tmb-365 & ... The long-acting combination of bNAbs (TMB-365/TMB-380) is safe. PK data suggests an every 8-week infusion for HIV maintenance therapy is feasible. CONCLUSIONS.