Clinical trial NCT05890963: 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
Official title: Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis
Conditions: HIV-1-infection
Summary: This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:
* Arm 1 will receive standard daily oral ART.
* Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
* Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
* Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
* Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.
Interventions:
description: ART is a combination of three or more drugs from different classes of antiretroviral medication.
name: ART
other_name: antiretroviral therapy
type: Drug
description: 10E8.4/iMab is an engineered bispecific antibody with two arms combined into a single molecule that exhibits synergistic enhancement of antiviral activity. 10E8.4/iMab will be administered IV at the 600mg or 1800mg dose or IM at 600mg dose to participants in Step 1 per the Schedule of Events (SOE) based on the arm the participant is assigned.
name: 10E8.4/iMab
other_name: ibalizumab
type: Drug
description: VRC07-523LS is an engineered variant of VRC01, a bNAb that targets the CD4 binding site of the HIV-1 envelope. VRC07-523LS will be administered IV at the 1200mg dose to participants in Step 1 per the SOE.
name: VRC07-523LS
other_name: VRC01 variant
type: Drug
Study arms:
design_group_description: Participants will receive standard daily oral ART.
design_group_title: Arm 1: Oral ART
design_group_type: Active Comparator
design_group_description: Participants will receive a single dose of 10E8.4/iMab 600mg IV.
design_group_title: Arm 2: 10E8.4/iMab 600mg IV.
design_group_type: Experimental
design_group_description: Participants will receive a single dose of 10E8.4/iMab 600mg IM.
design_group_title: Arm 3: 10E8.4/iMab 600mg IM.
design_group_type: Experimental
design_group_description: Participants will receive a single dose of 10E8.4/iMab 1800mg IV.
design_group_title: Arm 4:10E8.4/iMab 1800mg IV.
design_group_type: Experimental
design_group_description: Participants will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV. and VRC07-523LS 1200mg IV.
design_group_title: Arm 5: Combination 10E8.4/iMab and VRC07-523LS therapy
design_group_type: Experimental
Sponsor: Columbia University
Collaborators: The Henry M. Jackson Foundation
Drug name mappings:
name: 艾巴利珠单抗
lang: CN
name: Ibalizumab-UIYK
lang: EN
name: VRC-07-523
lang: EN