Trial · NCT07038382
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 24 weeks | Including incidence, nature, and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, and the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), abnormal laboratory tests, vital signs, physical examination, and 12-lead ECG |
| Secondary | Assessment of safety | 52 weeks | Safety: Proportion of subjects with at least one Grade 3 or greater infection-related AE in each dose group according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, and higher grades mean a worse outcome. |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Peak concentration (Cmax, Cmax, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Time to peak (Tmax, Tmax, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Area under the concentration-time curve (AUC0-inf, AUC0-t, AUC0-tau, AUCss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Elimination half-life (t1/2, t1/2, ss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Clearance (CL, CLss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Volume of distribution (Vz, Vss) |
| Secondary | Plasma concentrations and PK parameters of HLX79 and HLX01 | 52 weeks | Accumulation ratio (Rac) |
| Secondary | PD | 52 weeks | Proportion of subjects with peripheral blood CD19+ B lymphocyte count ≤ 5/μL at weeks 12, 24, 36, and 52 of treatment, and proportion of subjects with peripheral blood CD20+ B lymphocyte count ≤ 1/μL at weeks 12, 24, 36, and 52 of treatment |
| Secondary | Immunogenicity evaluation | 52 weeks | Positive rates of anti-drug antibody (ADA) and neutralizing antibody (NAb, if applicable) for HLX79 and HLX01 |
| Secondary | Assessment of clinical efficacy | 52 weeks | Proportion of subjects achieving complete remission (CR) or partial remission (PR) at weeks 12, 24, 36, and 52 of treatment. |
| Secondary | Assessment of clinical efficacy | 52 weeks | Proportion of subjects negative for anti-M-type phospholipase A2 receptor (PLA2R) antibodies at weeks 12, 24, 36, and 52 of treatment. |
| Secondary | Assessment of clinical efficacy | 52 weeks | Changes in anti-PLA2R antibody level from baseline at weeks 12, 24, 36, and 52 of treatment. |
| Secondary | Explore the biomarkers | 52 weeks | Peripheral blood B lymphocyte counts or B lymphocyte kinetics: including the depletion kinetics of B lymphocytes and their subsets (CD20+ B lymphocytes, CD19+ B lymphocytes, and memory B lymphocytes) |
| Secondary | Explore the biomarkers | 52 weeks | Peripheral blood B lymphocyte counts or B lymphocyte kinetics: the recovery kinetics of B lymphocytes and their subsets (e.g., CD20+ B lymphocytes, CD19+ B lymphocytes, and memory B lymphocytes). |
| Secondary | Explore the biomarkers | 52 weeks | Serum immunoglobulins (IgA, IgG, and IgM). |
| Secondary | Explore the biomarkers | 52 weeks | Serum complements (C3 and C4). |
| Secondary | Explore the biomarkers | 52 weeks | Urine CD163 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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