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

Summary

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.

Conditions

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

Sponsors & Collaborators

• California Institute for Regenerative Medicine (CIRM)

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Pharmacyclics LLC.

  collaborator INDUSTRY

• Oncternal Therapeutics, Inc

  lead INDUSTRY

Principal Investigators

• Michael Choi, MD · University of California, San Diego

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-03

Primary Completion

2024-09-25

Completion

2024-09-25

FDA Drug

Yes

Countries

• United States

Study Locations