NCT04501939

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.

Detailed description

This is a phase 2 study to test whether cirmtuzumab in combination with venetoclax given as consolidation therapy can decrease the number of cancer cells that may be left in the bone marrow or in the blood in patients who have been treated with venetoclax for at least one year. Consolidation therapy is given after initial cancer treatment to further reduce the number of cancer cells that may be left in the body. Cirmtuzumab, a monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor (ROR1) signaling and stemness, may be effective in reducing the risk of disease progression in patients with detectable minimal residual disease (MRD) after treatment with venetoclax.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Cirmtuzumab	Cycle 1, Day 1 \& 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg
DRUG	Venetoclax	Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.

Timeline

• Start date: 2020-08-06
• Primary completion: 2026-07-22
• Completion: 2026-07-22
• First posted: 2020-08-06
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study