Antibody-mediated RejectionPhase 2STABILIZENCT07902609
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
A Phase 2 study testing Methylprednisolone (MP), Daratumumab and Telitacicept in people with Antibody-mediated Rejection and Antibody-Mediated Rejection (AMR), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to: a. To evaluate the safety and efficacy of sequential daratumumab followed by telitacicept in kidney transplant recipients with active/chronic active ABMR in participants aged 18-70 years, time since kidney transplantation ≥180 days, meeting Banff 2022 criteria for active/chronic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
- What is being tested?
- Methylprednisolone (MP), Daratumumab and Telitacicept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ Age ≤ 70 years.
- Kidney transplant recipients meeting Banff 2022 criteria for active/chronic active ABMR: Diagnosis is based on kidney biopsy and HLA-DSA. Subjects may also be enrolled if they have concurrent other histopathological findings that are determined to be the primary cause of renal dysfunction along with ABMR. (Kidney biopsy must be performed within 90 days before screening or during the screening period).
- Time since kidney transplantation ≥ 180 days.
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m² (CKD-EPI formula).
- HLA Class I or Class II antibody with MFI > 1000 (pre-existing or de novo DSA).
- Recipient of a living-related or deceased donor kidney.
- Patients of childbearing potential (including male patients with female partners of childbearing potential) must agree to use effective contraception from the time of signing the informed consent form until 4 months after the last dose of the investigational product.
- Voluntary provision of written informed consent and ability to cooperate with follow-up visits.
Who cannot join
- Multi-organ transplant recipient.
- ABO blood group incompatibility.
- Pathology indicates concurrent lesions that are the primary cause of renal dysfunction: T-cell mediated rejection (TCMR) grade 1 or above, thrombotic microangiopathy (TMA), BK virus-associated nephropathy, de novo or recurrent glomerulonephritis.
- Pregnant or breastfeeding women.
- Intolerance to the triple immunosuppressive regimen of tacrolimus + mycophenolic acid + glucocorticoids.
- Patients with abnormal liver function: total bilirubin > 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 × ULN.
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- Patients with abnormal hematology: platelet count < 100×10⁹/L. or white blood cell count < 3×10⁹/L. or neutrophil count < 1.5×10⁹/L.
- Serum globulin < 4 g/L.
- Patients with active bacterial, fungal, or viral infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis B or C.
- Latent tuberculosis (positive tuberculin skin test or interferon-gamma release assay without clinical or radiographic evidence of active disease).
- Active malignancy, precluding intensive immunosuppressive therapy.
- History of alcohol or illicit drug abuse.
- History of severe medical or psychiatric illness.
- Use of acute rejection treatment (e.g., methylprednisolone pulse therapy, anti-thymocyte globulin (ATG)) or plasma exchange (PLEX) within 3 months before screening.
- Prior use of CD38 monoclonal antibody, BAFF inhibitor, BAFF/APRIL inhibitor, or other drugs with the same target as the investigational products.
- Use of CD20 monoclonal antibody, high-dose IVIG (1-2 g/kg), IL6/IL-6R antibody, etc., within 6 months before screening.
- Live vaccination within 6 weeks before screening.
- Participation in other clinical trials within 6 months before screening.
- Any other reason deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Sun yat-sen university
Guangzhou, Guangdong, 510000
About this study
Official title: STABILIZE Trial: Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
The goal of this clinical trial is to:
- To evaluate the safety and efficacy of sequential daratumumab followed by telitacicept in kidney transplant recipients with active/chronic active ABMR in participants aged 18-70 years, time since kidney transplantation ≥180 days, meeting Banff 2022 criteria for active/chronic active ABMR, and eGFR ≥20 mL/min/1.73m² (2021 CKD-EPI formula).
Read more
The main questions it aims to answer are:
What is the incidence of CTCAE v6.0 grade ≥3 adverse events during treatment? What are the changes from baseline in urine protein-to-creatinine ratio (UPCR), eGFR, urine albumin-to-creatinine ratio (UACR), and donor-specific antibody (DSA) mean fluorescence intensity (MFI) during the follow-up period?
If there is a comparison group:
Not applicable (single-arm study).
Participants will:
Receive the study-specified sequential regimen (daratumumab followed by telitacicept).Attend scheduled follow-up visits at weeks 4, 8, 12, 16, 20, 24, 36, and 52.Undergo laboratory tests (including UPCR, eGFR, UACR, DSA MFI, etc.) at each follow-up visit.During scheduled follow-up visits, investigators will promptly assess participants for the occurrence of adverse events (AEs), the grade of AEs (according to CTCAE v6.0), as well as efficacy outcomes.
- Being tested
- Methylprednisolone (MP), Daratumumab, Telitacicept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (MP)Drug
Methylprednisolone 250-500 mg once daily is given on Days 0, 1, and 2 (total of 3 doses)
DaratumumabDrug
Daratumumab (DARA) 1800 mg is administered starting on Day 4, followed by 1800 mg every 2 weeks (q2w) through Week 12.
TelitaciceptDrug
Telitacicept (TACI) 160 mg once weekly (qw) is given from Week 12 to Week 52.
| Study group | Role | What they receive |
|---|---|---|
| The Sequential regimen treatment group | Experimental | Hormone pulse therapy, followed by Daratumumab induction, then Telitacicept maintenance(on top of standard triple immunosuppression). Receives: Drug: Methylprednisolone (MP); Drug: Daratumumab; Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CTCAE v6.0 grade ≥ 3 adverse events (AEs) during the Phase A (0-24 weeks) follow-up period.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (2)
Incidence of AEs during the follow-up period (Phase B: 25-52 weeks).
Measured: From enrollment to the end of treatment at 52 weeks
Change in eGFR from baseline during the follow-up period
Measured: From enrollment to the of treatment at 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start20 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-mediated RejectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902609
- Sponsor's protocol ID
- 12100000455416029H
- Acronym
- STABILIZE
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STABILIZE Trial: Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
- ClinicalTrials.gov ID
- NCT07902609
- Acronym / sponsor ID
- STABILIZE / 12100000455416029H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to:
- To evaluate the safety and efficacy of sequential daratumumab followed by telitacicept in kidney transplant recipients with active/chronic active ABMR in participants aged 18-70 years, time since kidney transplantation ≥180 days, meeting Banff 2022 criteria for active/chronic active ABMR, and eGFR ≥20 mL/min/1.73m² (2021 CKD-EPI formula).
The main questions it aims to answer are:
What is the incidence of CTCAE v6.0 grade ≥3 adverse events during treatment? What are the changes from baseline in urine protein-to-creatinine ratio (UPCR), eGFR, urine albumin-to-creatinine ratio (UACR), and donor-specific antibody (DSA) mean fluorescence intensity (MFI) during the follow-up period?
If there is a comparison group:
Not applicable (single-arm study).
Participants will:
Receive the study-specified sequential regimen (daratumumab followed by telitacicept).Attend scheduled follow-up visits at weeks 4, 8, 12, 16, 20, 24, 36, and 52.Undergo laboratory tests (including UPCR, eGFR, UACR, DSA MFI, etc.) at each follow-up visit.During scheduled follow-up visits, investigators will promptly assess participants for the occurrence of adverse events (AEs), the grade of AEs (according to CTCAE v6.0), as well as efficacy outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Sequential regimen treatment group | Experimental | Drug: Methylprednisolone (MP), Drug: Daratumumab, Drug: TelitaciceptHormone pulse therapy, followed by Daratumumab induction, then Telitacicept maintenance(on top of standard triple immunosuppression). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years ≤ Age ≤ 70 years.
- Kidney transplant recipients meeting Banff 2022 criteria for active/chronic active ABMR: Diagnosis is based on kidney biopsy and HLA-DSA. Subjects may also be enrolled if they have concurrent other histopathological findings that are determined to be the primary cause of renal dysfunction along with ABMR. (Kidney biopsy must be performed within 90 days before screening or during the screening period).
- Time since kidney transplantation ≥ 180 days.
- Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m² (CKD-EPI formula).
- HLA Class I or Class II antibody with MFI > 1000 (pre-existing or de novo DSA).
Key exclusion criteria (19 listed)
- Multi-organ transplant recipient.
- ABO blood group incompatibility.
- Pathology indicates concurrent lesions that are the primary cause of renal dysfunction: T-cell mediated rejection (TCMR) grade 1 or above, thrombotic microangiopathy (TMA), BK virus-associated nephropathy, de novo or recurrent glomerulonephritis.
- Pregnant or breastfeeding women.
- Intolerance to the triple immunosuppressive regimen of tacrolimus + mycophenolic acid + glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone (MP)Methylprednisolone 250-500 mg once daily is given on Days 0, 1, and 2 (total of 3 doses) | Drug | The Sequential regimen treatment group |
| DaratumumabDaratumumab (DARA) 1800 mg is administered starting on Day 4, followed by 1800 mg every 2 weeks (q2w) through Week 12. | Drug | The Sequential regimen treatment group |
| TelitaciceptTelitacicept (TACI) 160 mg once weekly (qw) is given from Week 12 to Week 52. | Drug | The Sequential regimen treatment group |
Primary outcome
Incidence of CTCAE v6.0 grade ≥ 3 adverse events (AEs) during the Phase A (0-24 weeks) follow-up period.
Time frame: From enrollment to the end of treatment at 24 weeks
2 secondary outcomes
Incidence of AEs during the follow-up period (Phase B: 25-52 weeks).
Time frame: From enrollment to the end of treatment at 52 weeks
Change in eGFR from baseline during the follow-up period
Time frame: From enrollment to the of treatment at 24 weeks and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone (MP), Daratumumab and Telitacicept in people with Antibody-mediated Rejection and Antibody-Mediated Rejection (AMR), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CTCAE v6.0 grade ≥ 3 adverse events (AEs) during the Phase A (0-24 weeks) follow-up period. (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.