Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
- Trial number:
- NCT04240704
- Trial phase:
- 1
- Study type:
- Chemotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
September, 2020
Scientific title
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
Summary
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
For patients with CLL:
• Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
For patients with NHL:
Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Masking:
None (Open Label),
Conditions
Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia
Other study ID numbers
CJBH492A12101
Choose trial site (12)
Mayo Clinic Arizona
5701 E Mayo Blvd, Phoenix, AZ 85054, USA
Mayo Clinic Rochester
200 1st St SW, Rochester, MN 55905, USA
Medical College of Wisconsin
8701 W Watertown Plank Rd, Wauwatosa, WI 53226, USA
Novartis Investigative Site
Finland
Novartis Investigative Site
Totseret ha-Arets St 6, Tel Aviv-Yafo, Israel
Novartis Investigative Site
104-0045, Japan
Novartis Investigative Site
Singapore 169608
Novartis Investigative Site
Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Investigative Site
01307 Dresden, Germany
Novartis Investigative Site
79106 Freiburg im Breisgau, Germany
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Helsinki, Finland