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NCT05604742
Belimumab for Treatment of cGVHD Following Allo-HCT
Phase 1, PHASE2 trial testing Belimumab (Benlysta) in cGVHD. Withdrawn.
30 December 2024
Quick facts
| Lead sponsor | xuna |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 1 January 2022 |
| Primary completion | 30 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Belimumab (Benlysta) — full drug profile →
Conditions studied
- cGVHD — all drugs for cGVHD →
Sponsor
xuna — full company profile →
Who can join
Adults 18 to 65, any sex, with cGVHD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD), the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the rational for use of belimumab as treatment of chronic GvHD.The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab a treatment of cGvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on chronic GvHD,and we explored therapeutic dosage of belimumab.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05604742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for cGVHD
Currently open trials in the same condition.
- NCT07253259 — A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or · EARLY_PHASE1 · recruiting
- NCT07246031 — BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation · Phase 2 · recruiting
- NCT06920199 — Treatment of Refractory cGVHD by Donor-derived Treg Cell Injection Combined With Recombinant Human Interleukin-2 · EARLY_PHASE1 · recruiting
- NCT06663722 — Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease · Phase 2 · recruiting
- NCT06458127 — Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease · NA · active not recruiting
Other xuna trials
Trials by the same sponsor.
- NCT05341050 — A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML · recruiting
- NCT05604755 — Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT · Phase 2 · withdrawn
- NCT05092048 — A Study for PRO of CML in Real Word · unknown
- NCT04526223 — Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05604742 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by xuna
- Last refreshed: 18 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05604742.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing