A Phase 3 interventional study of Zuberitamab and standard corticosteroid treatment in Nephrotic Syndrome, sponsored by Children's Hospital of Fudan University. Not yet recruiting at 9 sites in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Children's Hospital of Fudan University · Phase 3, Interventional, and Treatment
Among 34 studies in Nephrotic Syndrome with a site in China — 19 open to participants now, 21 under way, 5 of them phase 3. Nephrotic Syndrome · China.
Among the 34 studies in Nephrotic Syndrome with a site in China, this one is the 6th largest by planned enrollment of the 25 interventional ones, is one of 5 that started in 2026, is one of 10 in phase 3, reaches primary completion later than 15 of the 20 other live ones, and was the 34th registered.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →19 of the 34 studies in Nephrotic Syndrome with a site in China are open now, in 1 country. Each count lists the studies.
Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 5 started in 2026.
Median enrollment 36 across the 25 interventional studies, 300 across the 9 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
3 of 34 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Children's Hospital of Fudan University has 5 studies filed under Nephrotic Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Nephrotic Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07612592Children's Hospital of Chongqing Medical UniversityThe Clinical Application Study of Obinutuzumab in Pediatric Refractory Nephrotic Syndrome | 2026-12-01 |
| NCT06161701Zhejiang Provincial People's HospitalSteroid Diabetes in Patients With Kidney Disease | 2026-12-31 |
Among the 34 studies in Nephrotic Syndrome with a site in China, from their registry updates:
The goal of this clinical trial is to learn whether adding Zuberitamab to standard corticosteroid therapy can help prevent relapse in children and adolescents aged 1 to 18 years with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). It will also learn about the safety of Zuberitamab.
The main questions it aims to answer are:
Researchers will compare Zuberitamab plus standard corticosteroid therapy to standard corticosteroid therapy alone to see whether adding Zuberitamab improves disease control.
Participants will:
Primary nephrotic syndrome (PNS) is the most common glomerular disease in children. Although 80-90% of affected children achieve complete remission after initial corticosteroid therapy and are classified as having steroid-sensitive nephrotic syndrome (SSNS), most experience disease relapse within the first year after onset. Approximately half subsequently develop frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS), requiring prolonged exposure to corticosteroids and additional immunosuppressive agents. Recurrent relapses and long-term immunosuppressive treatment are associated with substantial morbidity, including infection, impaired growth and development, metabolic complications, nephrotoxicity, and reduced quality of life.
B-cell depletion therapy has emerged as an effective strategy for relapsing nephrotic syndrome. Rituximab, an anti-CD20 monoclonal antibody, has demonstrated the ability to reduce relapse rates and maintain remission in children with FRNS/SDNS, even after withdrawal of corticosteroids and other immunosuppressive agents. Based on accumulating evidence, rituximab has been incorporated into international treatment guidelines. Building upon extensive clinical experience with rituximab, our group initiated an investigator-sponsored multicenter study evaluating early rituximab treatment in children with newly diagnosed SSNS. Long-term follow-up from this study suggested potential benefits in preventing relapse and demonstrated an acceptable safety profile.
Zuberitamab is a next-generation anti-CD20 monoclonal antibody developed through molecular engineering of rituximab. Compared with rituximab, preclinical studies have demonstrated enhanced antibody-dependent cellular cytotoxicity (ADCC), a larger steady-state volume of distribution, and more sustained B-cell depletion. Zuberitamab was approved in China in 2023 for the treatment of CD20-positive diffuse large B-cell lymphoma. In addition, its use in kidney diseases has been reported in retrospective cohort studies and other early clinical experiences, including patients with membranous nephropathy. However, evidence regarding its efficacy and safety in glomerular diseases, particularly in paediatric nephrotic syndrome, remains limited.
Current treatment strategies for childhood nephrotic syndrome primarily focus on managing relapses after they occur rather than preventing them during the early phase of disease. Whether early intervention with a potent anti-CD20 monoclonal antibody can modify the disease course and reduce future relapses remains uncertain. This study is designed to evaluate the efficacy and safety of early Zuberitamab administration in combination with standard corticosteroid therapy in children with newly diagnosed steroid-sensitive nephrotic syndrome.
This is a multicenter, open-label, randomized controlled trial conducted across nine pediatric nephrology centers in China. Children with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS) who achieve remission following standard corticosteroid treatment will be randomized at weeks 4-5 after remission to receive either Zuberitamab plus standard corticosteroid treatment or standard corticosteroid treatment alone. Participants will be followed prospectively for up to 12 months to assess disease relapse, cumulative corticosteroid exposure, safety outcomes, kidney function, and health-related quality of life.
The study aims to determine whether early addition of Zuberitamab at weeks 4-5 after remission, compared with standard corticosteroid treatment alone, can prolong time to first relapse within 12 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zuberitamab plus standard corticosteroid treatment: Zuberitamab 375 mg/m2 (max 500 mg) as a single IV dose after remission. Premedication 30 min prior includes oral antipyretic and antihistamine and IV methylprednisolone 1.6 mg/kg (max 48 mg); oral steroid withheld on infusion day. Standard corticosteroid treatment consists of oral prednisone/prednisolone per protocol taper. TMP-SMZ prophylaxis (TMP 3 mg/kg on alternate days, max SMZ 960 mg) is administered until CD19 recovery. Relapse is managed per protocol with corticosteroid re-induction and possible repeat zuberitamab after remission. Permitted and prohibited concomitant medications are the same as in the comparator arm.
Biological: Zuberitamab · Drug: standard corticosteroid treatment
Standard corticosteroid treatment: oral prednisone/prednisolone 2 mg/kg/day (max 60 mg) for 6 weeks, followed by 1.5 mg/kg (max 40 mg) on alternate days for 6 weeks, then discontinue. No zuberitamab, TMP-SMZ prophylaxis, or infusion premedication is given during initial treatment. Relapse is managed per protocol with corticosteroid re-induction; participants may receive zuberitamab after remission is re-achieved according to predefined criteria. Permitted concomitant medications include antihypertensives, calcium supplementation, anti-infective agents, antihistamines, anticoagulants, IVIG, hepatoprotective agents, glucose-lowering medications, and ophthalmic treatments. Prohibited therapies include other immunosuppressants (rituximab, CNIs, MMF, cyclophosphamide, plasma exchange) and Chinese herbal medicines for nephrotic syndrome (e.g., Huangkui, Huaiqihuang, Tripterygium). Live vaccines are prohibited during B-cell depletion.
Drug: standard corticosteroid treatment
Zuberitamab is administered as a single intravenous infusion at a dose of 375 mg/m² (maximum 500 mg) following achievement of steroid-sensitive remission. To reduce the risk of infusion-related reactions, premedication is administered approximately 30 minutes before infusion and may include: * Acetaminophen or ibuprofen; * Cetirizine, cyproheptadine, loratadine, or equivalent antihistamines; * Intravenous methylprednisolone 1.6 mg/kg (maximum 48 mg). Participants receiving zuberitamab also receive prophylactic trimethoprim-sulfamethoxazole (TMP 3 mg/kg every other day; maximum SMZ dose 960 mg every other day) until B-cell recovery. Infusion-related reactions are managed according to protocol-defined procedures, including infusion rate reduction, temporary interruption, permanent discontinuation when clinically indicated, and appropriate supportive therapy.
Also known as: Zuberitamab (BioRay Biopharmaceutical Co., Ltd.)
Drug pages: Prednisolone · Prednisone
standard corticosteroid treatment administered orally to treat steroid-sensitive nephrotic syndrome: 6 weeks at 2 mg/kg (max 60 mg/day), then alternate day steroid 1.5 mg/kg (max 40 mg on alternate days) for 6 weeks.
Also known as: prednisolone/prednisone
Relapse-free survival time within 12 months after randomization
Time from randomization to the first confirmed disease relapse during the 12-month follow-up period. Participants without relapse will be censored at the date of the last available assessment. Relapse is defined according to the 2023 International Pediatric Nephrology Association (IPNA) criteria as urine dipstick protein ≥3+ (≥300 mg/dL) or urine protein-to-creatinine ratio (UPCR) ≥200 mg/mmol (≥2 mg/mg) on a spot urine sample for three consecutive days, with or without edema, in a participant who previously achieved complete remission.
Time frame: From randomization until first relapse or 12 months after randomization, whichever occurs first.
Relapse-Free Survival Rate at 12 Months Post-Randomization
The proportion of participants who remain free from disease relapse at 12 months after randomization.
Time frame: 12 months post-randomization.
Relapse-Free Survival Rate at 6 Months Post-Randomization
The proportion of participants who remain free from disease relapse at 6 months after randomization.
Time frame: 6 months post-randomization.
Cumulative Steroid Dose at 12 Months Post-Randomization
The total amount of steroid medication (prednisolone) taken by participants from randomization until 12 months.
Time frame: 12 months post-randomization.
Change From Baseline in Serum Creatinine (Renal Function) at 12 Months
Change from baseline in serum creatinine levels to assess renal function.
Time frame: From baseline to 12 months post-randomization.
Change From Baseline in Serum Creatinine at the Time of Relapse
Change from baseline in serum creatinine levels measured at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months).
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 12 Months
Change from baseline in eGFR, calculated using an appropriate pediatric formula (e.g., the modified Schwartz formula), to assess renal function.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at the Time of Relapse
Change from baseline in eGFR at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scores at 12 Months
Change from baseline in total and domain-specific scores (physical, emotional, social, and school functioning) using the PedsQL 4.0 Chinese Standard Version (30-day recall) and PedsQL Infant scales (13-24 months). Scores range from 0 to 100, with higher scores indicating better quality of life. Includes child self-report (ages 5-18) and parent proxy (ages 2-18 and infants).
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scores at the Time of Relapse
Change from baseline in PedsQL total and domain scores measured at the time of disease relapse. Scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Systolic Blood Pressure Z-scores at 12 Months
Change from baseline in systolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in systolic Blood Pressure Z-scores at the Time of Relapse
Change from baseline in systolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in diastolic Blood Pressure Z-scores at 12 Months
Change from baseline in diastolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in diastolic Blood Pressure Z-scores at the Time of Relapse
Change from baseline in diastolic blood pressure, expressed as Z-scores relative to age-, sex-, and height-specific normative data.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Height Z-scores at 12 Months
Change from baseline in height, expressed as Z-scores relative to age- and sex-specific normative growth charts.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Height Z-scores at the Time of Relapse
Change from baseline in height Z-scores at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Weight Z-scores at 12 Months
Change from baseline in weight, expressed as Z-scores relative to age- and sex-specific normative growth charts.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Weight Z-scores at the Time of Relapse
Change from baseline in weight Z-scores at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Hemoglobin) at 12 Months
Change from baseline in hemoglobin levels.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Hemoglobin Levels) at the Time of Relapse
Change from baseline in hemoglobin levels at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Serum Albumin) at 12 Months
Change from baseline in serum albumin levels.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Serum Albumin) at the Time of Relapse
Change from baseline in serum albumin levels at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Change From Baseline in Laboratory Blood Parameters (Total Cholesterol) at 12 Months
Measurement of total cholesterol concentration in blood.
Time frame: From baseline to 12 months post-randomization
Change From Baseline in Laboratory Blood Parameters (Total Cholesterol) at the Time of Relapse
Change from baseline in total cholesterol levels at the acute phase of disease relapse.
Time frame: From baseline to the date of documented disease relapse (up to 12 months)
Time to CD19+ B-Cell Recovery
The time from CD19+ cell depletion until the first detection of CD19+ cells exceeding 1% of total CD45+ lymphocytes.
Time frame: From baseline to 12 months post-randomization
T-cell Immunophenotyping
Longitudinal assessment of peripheral blood T-cell subsets, including absolute counts and relative proportions of naïve T cells, central memory T cells, effector memory T cells, regulatory T cells, and other predefined T-cell populations measured by flow cytometry.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
B-cell Immunophenotyping
Longitudinal assessment of peripheral blood B-cell subsets, including absolute counts and relative proportions of naïve B cells, memory B cells, switched memory B cells, plasmablasts, CD19+ B cells, and other predefined B-cell populations measured by flow cytometry.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Cytokine Profiling
Longitudinal assessment of serum cytokine and chemokine concentrations associated with immune regulation and relapse risk, including but not limited to IL-7, IL-9, IL-15, VEGF, TGF-β3, RANTES, IL-10, IL-6, IFN-γ, and IL-4.
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months after randomization.
Incidence and Severity of Adverse Events (AEs)
Monitoring and recording of the frequency and severity of adverse events, including infusion-related reactions (e.g., nausea, rash, fever, chills, bronchospasm, hypertension, hypotension), infections (e.g., respiratory, HBV reactivation, VZV, Pneumocystis carinii pneumonia), cardiac events (e.g., fulminant myocarditis, heart failure), interstitial lung disease, inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), and abnormal laboratory findings (e.g., neutropenia, persistent hypogammaglobulinemia, elevated transaminases). Adverse events are graded according to NCI-CTCAE v5.0.
Time frame: From randomization through study completion, up to 12 months.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Zuberitamab
Children's Hospital of Fudan University →