Trial Outcomes & Findings for Extension Study of UC-961 (Cirmtuzumab) for Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961 (NCT NCT02860676)

NCT ID: NCT02860676

Last Updated: 2025-12-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: From start of investigational treatment to discontinuation from trial participation, on average 159 days
• Results posted on: 2025-12-15

Participant Flow

Participant milestones

Measure	Cirmtuzumab Cirmtuzumab 16 mg/kg
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cirmtuzumab n=3 Participants Cirmtuzumab 16 mg/kg
Age, Categorical <=18 years	0 Participants n=6009 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=6009 Participants
Age, Categorical >=65 years	3 Participants n=6009 Participants
Sex: Female, Male Female	1 Participants n=6009 Participants
Sex: Female, Male Male	2 Participants n=6009 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6009 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=6009 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6009 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6009 Participants
Race (NIH/OMB) Asian	0 Participants n=6009 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6009 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6009 Participants
Race (NIH/OMB) White	3 Participants n=6009 Participants
Race (NIH/OMB) More than one race	0 Participants n=6009 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6009 Participants
Region of Enrollment United States	3 participants n=6009 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Grade 1 Adverse Events n=3 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events n=3 Participants Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events n=3 Participants Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events n=3 Participants Number of CTCAE Grade 4 adverse events among all study subjects
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Generalized muscle weakness	1 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Eye disorders	1 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Abdominal pain	1 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Constipation	0 Adverse Events	1 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Gastrointestinal disorders, other	0 Adverse Events	1 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Dizziness	2 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Upper respiratory infection	0 Adverse Events	1 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Skin and subcutaneous tissue disorders, other	1 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Thrombocytopenia	7 Adverse Events	0 Adverse Events	0 Adverse Events	0 Adverse Events
Number of Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 Anemia	5 Adverse Events	1 Adverse Events	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Grade 1 Adverse Events n=3 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events Number of CTCAE Grade 4 adverse events among all study subjects
Overall Response Rate	0 percentage of participants	—	—	—

SECONDARY outcome

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

Population: Only one subject progressed after being on study at 16.66 months. The other two subjects did not progress but went off study at months 3.84 and 1.26, respectively; thus, their PFS status was censored at off study date.

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

Outcome measures

Measure	Grade 1 Adverse Events n=1 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events Number of CTCAE Grade 4 adverse events among all study subjects
Progression Free Survival (PFS)	16.66 months Standard Deviation 0	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Grade 1 Adverse Events n=3 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events Number of CTCAE Grade 4 adverse events among all study subjects
Stable Disease Rate (SD)	100 percentage of participants	—	—	—

SECONDARY outcome

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

Population: All 3 patients has stable disease while on treatment. Partial response rate is therefore 0%.

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

Outcome measures

Measure	Grade 1 Adverse Events n=3 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events Number of CTCAE Grade 4 adverse events among all study subjects
Partial Response Rate (PR)	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Grade 1 Adverse Events n=3 Participants Number of CTCAE Grade 1 adverse events among all study subjects	Grade 2 Adverse Events Number of CTCAE Grade 2 adverse events among all study subjects	Grade 3 Adverse Events Number of CTCAE Grade 3 adverse events among all study subjects	Grade 4 Adverse Events Number of CTCAE Grade 4 adverse events among all study subjects
Undetectable Minimal Residual Disease (uMRD) Rate	0 percentage of participants	—	—	—

Adverse Events

Cirmtuzumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cirmtuzumab n=3 participants at risk Cirmtuzumab 16 mg/kg
Eye disorders Eye disorders, other	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Gastrointestinal disorders Gastrointestinal disorders, other	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
General disorders Dizziness	33.3% 1/3 • Number of events 2 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Investigations Anemia	100.0% 3/3 • Number of events 6 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Investigations Thrombocytopenia	100.0% 3/3 • Number of events 7 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders, other	33.3% 1/3 • Number of events 1 • Adverse events were collected during treatment with cirmtuzumab and during the post-treatment follow-up period until the last subject's discontinuation from trial participation, on average 159 days.

Additional Information

Michael Choi, MD

University of California, San Diego

Phone: 858-534-1765

Email: mychoi@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place