Extension Study of UC-961 (Cirmtuzumab) for Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961

December 12, 2025 updated by: Catriona Jamieson, University of California, San Diego

A Phase 1 Extension Study to Determine the Safety of UC-961 (Cirmtuzumab) at the Recommended Phase 2 Dose for Retreatment of Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961

The purpose of the study is to investigate the safety of the investigational drug called cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer cells. Cirmtuzumab is considered experimental because its use is not approved by United States (US) Food and Drug Administration (FDA).

Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants when given for a duration of 6 to 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label extension study to determine the safety and tolerability of cirmtuzumab given to participants who enrolled and completed the initial phase 1 trial in CLL without a dose-limiting toxicity.

UC-961 is administered by intravenous infusion every 14 days for 4 doses, then every 28 days for 4 doses, after which responses will be assessed. Patients with an objective response (meeting working group criteria for partial response or complete response) will continue at the same dose and schema. Patients with stable disease or progressive disease are eligible to increase the dose of UC-961 for another 6-month course.

Duration of UC-961 administration is until disease progression, treatment intolerance, or lack of clinical benefit.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD19 and CD5).
  • Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline.

  • Must have measurable disease, including one of the following:

    • absolute lymphocyte count greater than 5000/microliter
    • lymphadenopathy greater than 1.5 cm in longest dimension
    • splenomegaly
    • bone marrow biopsy with residual CLL cells, or resultant bone marrow dysfunction
  • Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate hematologic function
  • Adequate renal function
  • Adequate hepatic function
  • Adequate coagulation tests

Exclusion Criteria:

  • Pregnant or breast-feeding women

  • May have had intervening therapy since completion of initial UC-961 dosing, but excluding the following:

    • Within 7 days of UC-961 restart, or 5 half-lives (if known), whichever is shorter: small molecule tyrosine kinase inhibitor (eg: ibrutinib, idelalisib, AVL-292, IPI-145);
    • Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961);
    • Within 56 days of UC-961 restart: previous UC-961 dosing;
    • Within 56 days of UC-961 restart: monoclonal antibody therapy directed against CLL (e.g., rituximab, ofatumumab, obinutuzumab, alemtuzumab).
  • Current infection requiring parenteral antibiotics.
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  • Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer).
  • Known central nervous system (CNS) involvement by malignancy.
  • Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
  • Uncompensated hypothyroidism (defined as thyroid stimulating hormone greater than 2x upper limit of normal not treated with replacement hormone).
  • Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded.
  • Insufficient recovery from surgical-related trauma or wound healing.

  • Impaired cardiac function including any of the following:

    • Myocardial infarction within 6 months of starting study drug;
    • A past medical history of clinically significant electrocardiogram (ECG) abnormalities;
    • Other clinically significant heart disease (e.g. uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cirmtuzumab
Cirmtuzumab 16 mg/kg administered every 14 days for 4 doses, then every 28 days for 4 doses via intravenous infusion.
Drug: cirmtuzumab
Other Names:
  • UC-961

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0
Time Frame: From start of investigational treatment to discontinuation from trial participation, on average 159 days
Adverse events (AE) assessed by CTCAE v4.0 during cirmtuzumab treatment and during 3 months of follow-up
From start of investigational treatment to discontinuation from trial participation, on average 159 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: From start of investigational treatment to discontinuation from trial participation, on average 159 days
Overall response rate by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria following 6 months of biweekly dosing of cirmtuzumab
From start of investigational treatment to discontinuation from trial participation, on average 159 days
Progression Free Survival (PFS)
Time Frame: From start of investigational treatment to tumor progression or death, on average 16.66 months
The duration of time from the start of study treatment until objective tumor progression or death determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
From start of investigational treatment to tumor progression or death, on average 16.66 months
Stable Disease Rate (SD)
Time Frame: From start of investigational treatment to discontinuation from trial participation, on average 159 days
The Stable Disease Rate based on number of subjects who have absence of disease progression as determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
From start of investigational treatment to discontinuation from trial participation, on average 159 days
Partial Response Rate (PR)
Time Frame: From start of investigational treatment to discontinuation from trial participation, on average 159 days
The percentage of subjects who achieve partial clinical response determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
From start of investigational treatment to discontinuation from trial participation, on average 159 days
Undetectable Minimal Residual Disease (uMRD) Rate
Time Frame: From start of investigational treatment to discontinuation from trial participation, on average 159 days
The Undetectable Minimal Residual Disease rate based on the number of subjects achieving undetectable minimal residual disease as determined by International Workshop on Chronic Lymphocytic Leukemia (iWCLL) criteria.
From start of investigational treatment to discontinuation from trial participation, on average 159 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Catriona Jamieson, MD, PhD, University of California, San Diego
  • Principal Investigator: Michael Y Choi, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2016

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

May 22, 2018

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimated)

August 9, 2016

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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