Experimental CLL drug cirmtuzumab tested for safety in retreatment
NCT ID NCT02860676
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested the safety of cirmtuzumab, an experimental antibody that targets a protein called ROR1 found on CLL cancer cells but rarely on healthy cells. Only 3 people with CLL who had previously received cirmtuzumab were retreated for 6 to 12 months. The main goal was to see if the drug is safe and tolerable, not whether it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cirmtuzumab (a monoclonal antibody that targets ROR1 on cancer cells)
- What this could lead to
- If it works, this could point toward a safer retreatment option for CLL that spares healthy cells.
- What could go wrong
- This is a very early, tiny study (only 3 people) focused on safety, not effectiveness. It may not work in humans or may have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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3 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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May 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?