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Monoclonal Antibodies

Cirmtuzumab + Ibrutinib for Lymphoma

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 from first dose of study drug to 30 days after the last dose of study drug or 72 weeks after accrual of the final subject

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).

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.

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.

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

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

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My cancer can be seen and measured on scans.

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

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

Exclusion Criteria

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

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My lymphoma has changed into a more aggressive form.

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I have a known brain or spinal cord tumor.

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

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I have signs of GVHD after a stem cell transplant.

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

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I have had a solid organ transplant.

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I cannot use ibrutinib due to a bleeding disorder.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 30 days after the last dose of study drug or 72 weeks after accrual of the final subject

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to 30 days after the last dose of study drug or 72 weeks after accrual of the final subject

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 30 days after the last dose of study drug or 72 weeks after accrual of the final subject for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Parts 1-2: Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.03

Parts 1-3: To evaluate Complete Response Rate

Parts 1-3: To evaluate Overall Response

Secondary study objectives

Part 3: Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.03

Parts 1, 2, 3:To evaluate Complete Response (CR)

Parts 1-2: Area under the serum concentration-time curve [AUC]

+11 more

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

~110

Cirmtuzumab (2-16 kg/mg) plus Ibrutinib

2018

Completed Phase 2

~110

Cirmtuzumab (300mg) plus Ibrutinib

2018

Completed Phase 2

~110

Cirmtuzumab (600 mg) plus ibrutinib

2018

Completed Phase 2

~110

Cirmtuzumab plus ibrutinib

2018

Completed Phase 2

~110

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,189 Previous Clinical Trials

1,587,606 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

3,254 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