NCT07287228 (DARA-AA-001) is a Phase 1, PHASE2 clinical trial of Daratumumab in Aplastic Anemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China.

Who is sponsoring NCT07287228?

NCT07287228 is sponsored by Institute of Hematology & Blood Diseases Hospital, China.

What drugs are being tested in NCT07287228?

Interventions in NCT07287228: Daratumumab.

What condition does NCT07287228 study?

NCT07287228 studies Aplastic Anemia, Refractory, Relapse.

Is NCT07287228 still recruiting?

NCT07287228 is currently not yet recruiting. Last updated 17 December 2025.

Last reviewed 2025-12-17 · How we verify

NCT07287228: DARA-AA-001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia

Not yet recruiting Phase 1, PHASE2 Last updated 17 December 2025

What this trial tests

Phase 1, PHASE2 trial testing Daratumumab in Aplastic Anemia in 37 participants. Not yet recruiting.

Timeline

10 December 2025

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Institute of Hematology & Blood Diseases Hospital, China
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	10 December 2025
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

Daratumumab (daratumumab) — full drug profile →

Conditions studied

Aplastic Anemia — all drugs for Aplastic Anemia →
Refractory — all drugs for Refractory →
Relapse — all drugs for Relapse →

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

18 and older, any sex, with Aplastic Anemia or Refractory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study consists of two phases, phase Ib and phase II. The primary objective of phase Ib is to evaluate the safety and tolerability of multiple doses of daratumumab in patients with refractory aplastic anemia. The primary objective of phase II is to preliminarily assess the efficacy of multiple doses of daratumumab in patients with refractory aplastic anemia. Secondary objectives include evaluation of other efficacy endpoints, safety (phase II), and pharmacodynamic characteristics of multiple doses of daratumumab in these patients. The exploratory objective is to assess biological functional changes in peripheral blood and bone marrow before and after daratumumab treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Daratumumab

Trials testing the same drug.

NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07393282 — A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) · Phase 3 · not yet recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting

Other recruiting trials for Aplastic Anemia

Currently open trials in the same condition.

NCT07101770 — A Prediction Model in Pregnant Women With Aplastic Anemia · recruiting
NCT06752694 — Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult P · Phase 2 · recruiting
NCT06936930 — Reproductive and Mental Health of Patients With Aplastic Anemia · recruiting
NCT06689800 — Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy · NA · recruiting
NCT06613880 — Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia · Phase 2 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07287228 (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 Institute of Hematology & Blood Diseases Hospital, China
Last refreshed: 17 December 2025

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/NCT07287228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing