← Back to Search

Monoclonal Antibodies

Cirmtuzumab + Ibrutinib for Lymphoma

La Jolla, CA

Phase 1 & 2

Waitlist Available

Led By Michael Choi, MD

Research Sponsored by Oncternal Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0, 1, or 2

Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy

Must not have

Known histological transformation to an aggressive lymphoma

Known central nervous system malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective when given with another drug to patients with B-cell lymphoid malignancies (cancer).

See full description

Who is the study for?

Adults with certain B-cell lymphoid malignancies (like CLL, MCL, or MZL) who've had prior treatments except those resistant to BTK inhibitors. Participants must have adequate organ function and no other cancers that could interfere. They should not be pregnant or breastfeeding and must agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the combination of cirmtuzumab, a monoclonal antibody targeting ROR1 on tumor cells, with ibrutinib versus ibrutinib alone in patients with specific types of blood cancer. It's designed to assess safety and effectiveness in Phase 1b/2.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system due to the monoclonal antibody (cirmtuzumab), bleeding risks from ibrutinib, possible infections, fatigue, digestive issues, and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

show original

Select...

My cancer can be seen and measured on scans.

show original

Select...

I need treatment because my symptoms or cancer spread are getting worse.

show original

Select...

My medical records show I have CLL/SLL, MCL, or MZL.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My lymphoma has changed into a more aggressive form.

show original

Select...

I have a known brain or spinal cord tumor.

show original

Select...

I have a stomach or intestine condition that could affect how medicine is absorbed.

show original

Select...

I have signs of GVHD after a stem cell transplant.

show original

Select...

I do not have an ongoing infection when starting the study treatment.

show original

Select...

I have had a solid organ transplant.

show original

Select...

I cannot use ibrutinib due to a bleeding disorder.

show original

Select...

I do not have another cancer that could impact my safety or the study's results.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response

Secondary study objectives

Duration of Response

Overall Survival

Progression Free Survival (PFS)

+1 more

Side effects data

From 2024 Phase 1 & 2 trial • 95 Patients • NCT03088878

100%

Diarrhoea

67%

Fatigue

33%

Thrombocytopenia

100%

80%

60%

40%

20%

Study treatment Arm

MCL Phase 1b, Part 1: 8mg/kg

MCL Phase 1b, Part 1: 2mg/kg

MCL Phase 1b, Part 1: 4mg/kg

MCL Phase 1b, Part 1: 16 mg/kg

MCL Phase 1b, Part 2: 600 mg

CLL Phase 1b, Part 1: 2 mg/kg

CLL Phase 1b, Part 1: 4 mg/kg

CLL Phase 1b, Part 1: 8 mg/kg

CLL Phase 1b, Part 1: 16 mg/kg

CLL Phase 1b, Part 1: 300 mg

CLL Phase 1b, Part 1: 600 mg

CLL Phase 1b, Part 2: 600 mg

CLL Phase 2, Part 3: 600 mg

CLL Phase 2, Part 3: Ibrutinib Alone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 3 - Arm AExperimental Treatment1 Intervention

Cirmtuzumab plus ibrutinib

Group II: Part 2Experimental Treatment1 Intervention

Cirmtuzumab plus ibrutinib

Group III: Part 1Experimental Treatment3 Interventions

Cirmtuzumab followed by Cirmtuzumab plus ibrutinib

Group IV: Part 3 - Arm BActive Control1 Intervention

Ibrutinib only

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cirmtuzumab (RDR) plus ibrutinib

2018

Completed Phase 2

~100

Cirmtuzumab (2-16 kg/mg) plus Ibrutinib

2018

Completed Phase 2

~100

Cirmtuzumab (300mg) plus Ibrutinib

2018

Completed Phase 2

~100

Cirmtuzumab (600 mg) plus ibrutinib

2018

Completed Phase 2

~100

Cirmtuzumab plus ibrutinib

2018

Completed Phase 2

~100

0 / 12Eligibility criteria met

Find a Location

Closest Location:UCSD Moores Cancer Center· La Jolla, CA

Who is running the clinical trial?

University of California, San DiegoOTHER

1,214 Previous Clinical Trials

1,593,094 Total Patients Enrolled

Pharmacyclics LLC.Industry Sponsor

113 Previous Clinical Trials

13,747 Total Patients Enrolled

Oncternal Therapeutics, IncLead Sponsor

6 Previous Clinical Trials

142 Total Patients Enrolled

California Institute for Regenerative Medicine (CIRM)OTHER

69 Previous Clinical Trials

3,184 Total Patients Enrolled

Michael Choi, MDPrincipal Investigator - University of California, San Diego

Regents Of The University Of California -Ucsd Physician Assoc, Regents of the University of California - UCSD Medical Group, UC San Diego Health System-Hillcrest, UCSD Medical Center-Hillcrest

7 Previous Clinical Trials

33 Total Patients Enrolled