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

NCT02860676 | Completed Phase 1 Results DMC

• 1 other identifier: 150851
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL; cancer; UC-961; cirmtuzumab

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

• Overall Response Rate

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

• Progression Free Survival (PFS)

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

• Stable Disease Rate (SD)

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

• Partial Response Rate (PR)

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

• Undetectable Minimal Residual Disease (uMRD) Rate

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

Study Arms (1)

Cirmtuzumab

EXPERIMENTAL

Cirmtuzumab 16 mg/kg administered every 14 days for 4 doses, then every 28 days for 4 doses via intravenous infusion.

Drug: cirmtuzumab

Interventions

cirmtuzumab DRUG

Also known as: UC-961

Cirmtuzumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 29859176 BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms

Interventions

cirmtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; 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

Results Point of Contact

• Title: Michael Choi, MD
• Organization: University of California, San Diego

mychoi@ucsd.edu

858-534-1765

Study Officials

• Catriona Jamieson, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Michael Y Choi, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: August 9, 2016
• Study Start: November 3, 2016
• Primary Completion: February 27, 2018
• Study Completion: May 22, 2018
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-12

Locations

US (1)