Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05261191 | A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy | PHASE1 | COMPLETED | 17 | — | — | Sep 26, 2022 | May 29, 2024 | Mar 28, 2025 | 3 | United States |
Observation of side effects determines the highest safe dose for further study
Observation of side effects determines the highest safe dose for further study
Observation of side effects determines the highest safe dose for further study
| Arm | Type | Description |
|---|---|---|
| Part 1A: Dose level 1 | EXPERIMENTAL | Single dose MGD020 |
| Part 1A: Dose level 2 | EXPERIMENTAL | Single dose MGD020 |
| Part 1A: Dose level 3 | EXPERIMENTAL | Single dose MGD020 |
| Part 1A: Dose level 4 | EXPERIMENTAL | Single dose MGD020 |
| Part 1A: Dose level 5 | EXPERIMENTAL | Single dose MGD020 |
| Part 1A: Dose level 6 | EXPERIMENTAL | Single dose MGD020 |
| Part 1B: MTD/MAD -1 MGD020 and MGD014 | EXPERIMENTAL | Single dose MGD020 and MGD014 |
| Part 1B: MTD/MAD MGD020 and MGD014 | EXPERIMENTAL | Single dose MGD020 and MGD014 |
| Part 2: MGD020 and MGD014 | EXPERIMENTAL | Multiple doses of MGD020 and MGD014 |
| Name | Type | Description |
|---|---|---|
| MGD020 | BIOLOGICAL | MGD020 is a bispecific DART molecule that binds CD3 and gp41 subunit of HIV-1 envelope. |
| MGD014 | BIOLOGICAL | MGD014 is a bispecific DART molecule that binds CD3 and gp120 subunit of HIV-1 envelope. |
Inclusion Criteria: * Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent * HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test. * Plasma HIV-1 RNA viral load * \< 50 copies/mL at 2 time point...