Safety and blood activity of the antibody BNT351 in adults with and without HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study has two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose first-in-human evaluation in adults without HIV, and Part B is an open-label, single-dose proof-of-concept cohort enrolling adults living with HIV. Part A includes four cohorts testing one subcutaneous dose and three intravenous doses with randomization to BNT351 or placebo and about 38 weeks of follow-up after dosing. Part B will enroll people with recent HIV diagnosis or who have recently stopped ART to receive a single dose of BNT351 and undergo up to 8 weeks of viral load monitoring before restarting combination antiretroviral therapy, with longer safety follow-up. Progression to Part B depends on review of safety data from Part A.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

Part A:

* Are HIV-1 and HIV-2 negative at Visit 0.
* Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:

  1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
  2. Agree to discuss HIV disease risks;
  3. Agree to HIV acquisition risk reduction counseling;

Part B:

* Are HIV-1 positive and HIV-2 negative at Visit 0.
* Individuals who at Visit 0:

  1. Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.
  2. If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \[ART\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.
  3. Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
  4. Have a CD4+ T cell count of ≥500 cells/µL and plasma HIV-1 RNA levels between 5,000-100,000 copies/mL at screening.
  5. Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).
  6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.

Key Exclusion Criteria:

Parts A and B:

* Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
* Have a known or suspected impairment/alteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.
* Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients.

Part B only:

* Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
* Have a history of opportunistic infections/AIDS-defining illnesses as defined in the protocol.
* Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
* Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence.

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Where it's running

• Cook County Health
  Chicago, Illinois, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• UK Köln
  Cologne, Germany Recruiting
• CRS Mannheim
  Mannheim, Germany Active not recruiting

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.