Last reviewed · How we verify
NCT05676697
PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy
Phase 1 trial testing Linperlisib in Autoimmune Hemolytic Anemia in 4 participants. Terminated before completion.
31 January 2024
Quick facts
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 13 January 2023 |
| Primary completion | 31 January 2024 |
| Estimated completion | 6 February 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Linperlisib — full drug profile →
Conditions studied
- Autoimmune Hemolytic Anemia — all drugs for Autoimmune Hemolytic Anemia →
- Failure of Two Rounds of Treatment — all drugs for Failure of Two Rounds of Treatment →
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Who can join
18 and older, any sex, with Autoimmune Hemolytic Anemia or Failure of Two Rounds of Treatment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
ChemAP: predicting drug approval with chemical structures before clinical trial phase by leveraging multi-modal embedding space and knowledge distillation.
Cho C, Lee S, Bang D, Piao Y, et al · · 2024 · cited 1× · PMID 39362916 · DOI 10.1038/s41598-024-72868-0 -
[The treatment strategies of autoimmune hemolytic anemia].
Yue WR, Wu T, Wang XQ. · · 2024 · cited 1× · PMID 39134500 · DOI 10.3760/cma.j.cn121090-20231027-00236
Verify or expand the search:
- PubMed search for NCT05676697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Linperlisib
Trials testing the same drug.
- NCT07139353 — Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma · Phase 1, PHASE2 · not yet recruiting
- NCT07031115 — Linperlisib in the Treatment of aPRCA · Phase 2 · not yet recruiting
- NCT06548347 — A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma · Phase 2, PHASE3 · not yet recruiting
- NCT06489808 — Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL · Phase 2 · recruiting
- NCT06343935 — A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma · Phase 4 · not yet recruiting
Other recruiting trials for Autoimmune Hemolytic Anemia
Currently open trials in the same condition.
- NCT07441525 — UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases · EARLY_PHASE1 · recruiting
- NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia · Phase 1, PHASE2 · recruiting
- NCT06921980 — Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia · recruiting
- NCT06733610 — CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy. · Phase 1 · recruiting
- NCT06888960 — Safety Study of CC312 in Autoimmune Disease Patients · EARLY_PHASE1 · recruiting
Other Institute of Hematology & Blood Diseases Hospital, China trials
Trials by the same sponsor.
- NCT06991920 — Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage · NA · not yet recruiting
- NCT07407010 — BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM · Phase 1 · not yet recruiting
- NCT07407140 — VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML · Phase 3 · not yet recruiting
- NCT07454226 — ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL · NA · not yet recruiting
- NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet recruiting
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 NCT05676697 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Hematology & Blood Diseases Hospital, China
- Last refreshed: 11 February 2026
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/NCT05676697.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing