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Chronic Lymphocytic LeukemiaPhase 1NCT02860676

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

A Phase 1 study testing cirmtuzumab in people with Chronic Lymphocytic Leukemia, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
cirmtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
3 Nov 2016to 22 May 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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).
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
cirmtuzumab
Keywords
CLL, cancer, UC-961, cirmtuzumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cirmtuzumabDrug

    Also called UC-961

Study groups in NCT02860676
Study groupRoleWhat they receive
CirmtuzumabExperimentalCirmtuzumab 16 mg/kg administered every 14 days for 4 doses, then every 28 days for 4 doses via intravenous infusion.
Receives: Drug: cirmtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0

    Adverse events (AE) assessed by CTCAE v4.0 during cirmtuzumab treatment and during 3 months of follow-up

    Measured: From start of investigational treatment to discontinuation from trial participation, on average 159 days

Secondary outcomes (5)

  1. Overall Response Rate

    Overall response rate by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria following 6 months of biweekly dosing of cirmtuzumab

    Measured: From start of investigational treatment to discontinuation from trial participation, on average 159 days

  2. Progression Free Survival (PFS)

    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

    Measured: From start of investigational treatment to tumor progression or death, on average 16.66 months

  3. Stable Disease Rate (SD)

    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.

    Measured: From start of investigational treatment to discontinuation from trial participation, on average 159 days

  4. Partial Response Rate (PR)

    The percentage of subjects who achieve partial clinical response determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.

    Measured: From start of investigational treatment to discontinuation from trial participation, on average 159 days

  5. Undetectable Minimal Residual Disease (uMRD) Rate

    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.

    Measured: From start of investigational treatment to discontinuation from trial participation, on average 159 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start3 Nov 2016
  3. Primary completion27 Feb 2018
  4. Study completion22 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860676
Sponsor's protocol ID
150851
Status last verified
Dec 2025
First submitted
9 Jun 2016
Last updated
15 Dec 2025
Data monitoring committee
Yes

Publications

  • Choi MY, Widhopf GF 2nd, Ghia EM, Kidwell RL, Hasan MK, Yu J, Rassenti LZ, Chen L, Chen Y, Pittman E, Pu M, Messer K, Prussak CE, Castro JE, Jamieson C, Kipps TJ. Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia. Cell Stem Cell. 2018 Jun 1;22(6):951-959.e3. doi: 10.1016/j.stem.2018.05.018.

    PubMed 29859176

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cirmtuzumab in people with Chronic Lymphocytic Leukemia, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02860676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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