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

Part of paid clinical trials in Duarte, California.

Sponsor
Oncternal Therapeutics, Inc
Study ID
NCT03088878
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-cell Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cirmtuzumab (2-16 kg/mg) plus Ibrutinib — DRUG
    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.
  • Cirmtuzumab (300mg) plus Ibrutinib — DRUG
    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.
  • Cirmtuzumab (600 mg) plus ibrutinib — DRUG
    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.
  • Cirmtuzumab (RDR) plus ibrutinib — DRUG
    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
  • Cirmtuzumab plus ibrutinib — DRUG
    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.
  • Ibrutinib alone — DRUG
    Arm B: Participants will receive ibrutinib (420 mg) orally once daily

Study Details

This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1) that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell signaling that cause leukemia and lymphoma cells to grow and survive. ROR1 is rarely found on healthy cells.

Key Dates

Start date
Jan 3, 2018
Status verified
Jan 2025
Primary completion
Sep 25, 2024
Completion
Sep 25, 2024

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Cirmtuzumab followed by Cirmtuzumab plus ibrutinib
  • Experimental: Part 2
    Cirmtuzumab plus ibrutinib
  • Experimental: Part 3 - Arm A
    Cirmtuzumab plus ibrutinib
  • Active Comparator: Part 3 - Arm B
    Ibrutinib only

Primary Outcome Measure

Overall Response [ Time Frame: up to 5 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
Sanford Stem Cell Clinical Center at UCSDLa JollaCalifornia92093-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Yale Cancer CenterNew HavenConnecticut06510-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Louisiana State University Health New Orleans (NCI Community Oncology Research Program)New OrleansLouisiana70112-
Hackensack Meridian Health, John Theurer Cancer CenterHackensackNew Jersey07601-
Northwell HealthNew Hyde ParkNew York11042-
Columbia University Medical CenterNew YorkNew York10032-
Manhattan Hematology Oncology Research Foundation, Inc.New YorkNew York10016-
The Christ Hospital Lindner Research CenterCincinnatiOhio45219-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CASanford Stem Cell Clinical Center at UCSD· La Jolla, CAUC Davis Comprehensive Cancer Center· Sacramento, CAYale Cancer Center· New Haven, CTWinship Cancer Institute of Emory University· Atlanta, GALouisiana State University Health New Orleans (NCI Community Oncology Research Program)· New Orleans, LA

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