A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

January 3, 2018

Primary Completion Date

September 25, 2024

Study Completion Date

September 25, 2024

Conditions
B-cell Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMantle Cell LymphomaMarginal Zone Lymphoma
Interventions
DRUG

Cirmtuzumab (2-16 kg/mg) plus Ibrutinib

Participants will receive escalating doses of cirmtuzumab (2-16 mg/kg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 or 560 mg) orally once daily, starting at week 4.

DRUG

Cirmtuzumab (300mg) plus Ibrutinib

Participants will receive cirmtuzumab (300 mg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.

DRUG

Cirmtuzumab (600 mg) plus ibrutinib

Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.

DRUG

Cirmtuzumab (RDR) plus ibrutinib

Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 3 administrations and then every 4 weeks thereafter, plus ibrutinib (420 or 560 mg) orally once daily

DRUG

Cirmtuzumab plus ibrutinib

Arm A: Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 3 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.

DRUG

Ibrutinib alone

Arm B: Participants will receive ibrutinib (420 mg) orally once daily

Trial Locations (12)

10016

Manhattan Hematology Oncology Research Foundation, Inc., New York

10032

Columbia University Medical Center, New York

11042

Northwell Health, New Hyde Park

30322

Winship Cancer Institute of Emory University, Atlanta

45219

The Christ Hospital Lindner Research Center, Cincinnati

70112

Louisiana State University Health New Orleans (NCI Community Oncology Research Program), New Orleans

77030

MD Anderson Cancer Center, Houston

91010

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte

92093

Sanford Stem Cell Clinical Center at UCSD, La Jolla

95817

UC Davis Comprehensive Cancer Center, Sacramento

06510

Yale Cancer Center, New Haven

07601

Hackensack Meridian Health, John Theurer Cancer Center, Hackensack

Sponsors
All Listed Sponsors
collaborator

California Institute for Regenerative Medicine (CIRM)

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Oncternal Therapeutics, Inc

INDUSTRY