A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHinge Bio
About this trial
This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Meet 2019 ACR / 2023 EULAR SLE classification criteria
Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
Disqualifiers
Meet 2019 ACR / 2023 EULAR SLE classification criteria
Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)
LN participants: biopsy confirmed active Class III/IV ± V or Class V LN; proteinuria ≥0.8 g/g; eGFR ≥30 mL/min/1.73 m²
ERL participants: inadequate response/intolerance to ≥1 standard SLE therapy
Trial design
Design model
Single group
Treatments tested in this trial
HB2198
DrugHB2198, a Tetravalent Bispecific Anti-CD19/CD20 Antibody with Dual Fc Domains
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: HB2198Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Safety and tolerability will be assessed primarily by the incidence of TEAEs and SAEs. Supporting safety data (e.g., clinical laboratory values, vital signs, ECG results, physical examinations, and renal function assessments) will be reviewed descriptively to aid interpretation of tolerability but will not be reported as separate outcome measures.
Time frame
Day 1, Day 8, Day 14, Day 292
Maximum tolerated dose (MTD)
MTD will be determined based on the incidence of dose-limiting toxicities (DLTs) according to protocol-defined criteria. Laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to evaluate DLTs but will not be individually reported as outcome measures.
Time frame
Day 1, Day 8, Day 14, Day 293
Number of participants experiencing dose-limiting toxicities (DLTs)
DLTs will be evaluated based on protocol-defined criteria. Supporting safety data (e.g., labs, vitals, ECGs, physical exams, renal assessments) will be used to determine DLT classification but will not be reported as separate outcome measures.
Time frame
Day 1, Day 8, Day 14, Day 294
Recommended Phase 2 Dose (RP2D)
The RP2D will be selected using an integrated assessment of DLTs, TEAEs, and overall tolerability, based on protocol-defined safety criteria. Clinical laboratory results, vital signs, ECGs, physical examinations, and renal assessments will be used to inform dose selection but will not be individually reported.
Time frame
Day 1, Day 8, Day 14, Day 29Secondary outcomes
1
To characterize the pharmacokinetic (PK) profile of HB2198
Concentration of HB2198 and PK parameters such as, area under the concentration versus time curve (AUC)
Time frame
Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 122
To characterize the pharmacokinetic (PK) profile of HB2198
Concentration of HB2198 and PK parameters such as maximum drug concentration (Cmax)
Time frame
Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 123
To characterize the pharmacokinetic (PK) profile of HB2198
Concentration of HB2198 and PK parameters such as time to maximum plasma concentration (tmax)
Time frame
Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 124
To evaluate the development of anti-drug antibodies (ADAs)
Proportion of participants developing ADAs
Time frame
Multiple timepoints collected before and after infusion on dosing days (Day 1, Day 8), and during the follow-up period on Day 14, Day 29, Month 3, Month 12 Source ClinicalTrials.gov