Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

NCT04501939 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 191407
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemia; CLL; cirmtuzumab; venetoclax

Outcome Measures

Primary Outcomes (1)

• Cancer response to treatment

  Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.

  6-24 months

Secondary Outcomes (2)

• Frequency of adverse events

  9-15 months

• Time to next CLL treatment.

  9-24 months

Other Outcomes (1)

• Change in gene expression in leukemic cells

  9-15 months

Study Arms (1)

Cirmtuzumab + Venetoclax

EXPERIMENTAL

All patients will receive a minimum of 6 cycles (cycle = 28 days) of therapy with venetoclax and cirmtuzumab during the treatment period. For patients who achieve undetectable minimal residual disease (uMRD) positive after cycle 6, an additional 6 cycles of venetoclax and cirmtuzumab may be administered.

Drug: Cirmtuzumab; Drug: Venetoclax

Interventions

Cirmtuzumab DRUG

Cycle 1, Day 1 \& 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg

Also known as: Zilovertamab

Cirmtuzumab + Venetoclax

Venetoclax DRUG

Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.

Also known as: VENCLEXTA

Cirmtuzumab + Venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have detectable CLL/SLL (\> 0.01% leukemia cells present)
• Must have received at least 12 months of venetoclax.
• Patients may be receiving venetoclax at the time of screening and study entry.
• Patients who have discontinued venetoclax more than 6 months prior to study entry must still have a disease burden meeting criteria for low risk of TLS (i.e. no lymph node greater than 5 cm in diameter; absolute lymphocyte count less than 25 k/uL)

You may not qualify if:

• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
• Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
• Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
• Child class B or C cirrhosis
• Treatment with any of the following within 7 days prior to the first dose of cirmtuzumab:
• Steroid therapy for anti-neoplastic intent
• Biologic agent (monoclonal antibody) within 30 days for anti-neoplastic intent.
• Chemotherapy (purine analog or alkylating agent) or target small molecule agent within 14 days or 5 half-lives (whichever is shorter), or has not recovered to less than CTCAE grade 2 clinically significant adverse effect(s)/toxicity(s) of previous therapy.
• CLL therapy, aside from venetoclax.
• History of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible.)
• Women who are pregnant or lactating

Sponsors & Collaborators

• University of California, San Diego: lead
• Oncternal Therapeutics, Inc: collaborator

Study Sites (1)

UCSD Koman Family Outpatient Pavilion

San Diego, California, 92037, United States

Location

Related Publications (1)

• Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.

  PMID: 34398557 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

cirmtuzumab; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin M Heyman, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clin Professor

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 6, 2020
• Study Start: August 6, 2020
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)