Cusatuzumab

Generic Name: Cusatuzumab

Drug Type: Biotech

CAS Number: 1864871-20-4

Unique Ingredient Identifier: RR5U4UFJ8L

Background: CD70 is a ligand expressed on the surface of activated lymphocytes and mature dendritic cells that, in its binding to CD27 receptors, plays an important role in cell proliferation and survival. An overexpression of CD70 can result in the proliferation of malignant cells and has been documented in a variety of solid and hematological malignancies.

Cusatuzumab is a humanized IgG1 antibody targeted against CD70. It is currently being investigated in the Phase 2 CULMINATE trial, in combination with azacitidine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in patients unsuitable for chemotherapy.

Clinical Trials

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Phase 2

Recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Cusatuzumab
Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2024-04-25

Last Posted Date: 2025-04-16

Lead Sponsor: OncoVerity, Inc.

Target Recruit Count: 120

Registration Number: NCT06384261

Locations: 🇺🇸
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus, Aurora, Colorado, United States
🇺🇸
AdventHealth Medical Group Blood & Marrow Transplant at Orlando, Orlando, Florida, United States
🇺🇸
The University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States

and more 27 locations

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

Phase 2

Withdrawn

Conditions: Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic

Interventions: Drug: Azacitidine
Drug: Cusatuzumab

First Posted Date: 2020-02-11

Last Posted Date: 2022-05-20

Lead Sponsor: Janssen Research & Development, LLC

Registration Number: NCT04264806

Locations: 🇸🇦
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
🇨🇭
UniversitaetsSpital Zuerich, Zürich, Switzerland
🇦🇺
St Vincents Hospital Sydney, Darlinghurst, Australia

and more 70 locations

A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Cusatuzumab
Drug: Azacitidine

First Posted Date: 2020-01-27

Last Posted Date: 2023-08-09

Lead Sponsor: OncoVerity, Inc.

Target Recruit Count: 6

Registration Number: NCT04241549

Locations: 🇯🇵
Fukushima Medical University Hospital, Fukushima, Japan
🇯🇵
Osaka City General Hospital, Osaka, Japan
🇯🇵
University of Fukui Hospital, Yoshida, Japan

and more 2 locations

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Cusatuzumab
Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2019-11-05

Last Posted Date: 2025-04-17

Lead Sponsor: OncoVerity, Inc.

Target Recruit Count: 61

Registration Number: NCT04150887

Locations: 🇵🇱
Szpital Uniwersytecki w Krakowie, Krakow, Poland
🇨🇭
Kantonsspital St.Gallen, St. Gallen, Switzerland
🇵🇱
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, Poland

and more 20 locations

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Phase 2

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Azacitidine
Drug: Cusatuzumab

First Posted Date: 2019-07-17

Last Posted Date: 2025-02-28

Lead Sponsor: OncoVerity, Inc.

Target Recruit Count: 103

Registration Number: NCT04023526

Locations: 🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇷🇺
Oncologic Dispensary No.2, Sochi, Russian Federation
🇷🇺
Komi Republic Oncology dispensary, Syktyvkar, Russian Federation

and more 53 locations