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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
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

Study 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.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
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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.

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1:To determine the Recommended dosing regimen (RDR) of cirmtuzumab within the tested dose range in combination of ibrutinib
Part 2: To determine the Recommended dosing regimen (RDR) of cirmtuzumab in combination with ibrutinib
Parts 1-2: Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.03
+2 more
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,533 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,718 Total Patients Enrolled
Oncternal Therapeutics, IncLead Sponsor
6 Previous Clinical Trials
228 Total Patients Enrolled

Media Library

Cirmtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03088878 — Phase 1 & 2
Mantle Cell Lymphoma Research Study Groups: Part 3 - Arm B, Part 3 - Arm A, Part 1, Part 2
Mantle Cell Lymphoma Clinical Trial 2023: Cirmtuzumab Highlights & Side Effects. Trial Name: NCT03088878 — Phase 1 & 2
Cirmtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03088878 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participation in this experiment?

"Absolutely, clinicaltrials.gov has explicit information that indicates this medical trial is actively enrolling patients. The project was initially posted on March 1st 2018 and the most recent update came on June 16th 2022. 138 individuals from 9 different sites are required for successful completion of the study."

Answered by AI

How many participants are involved in this trial?

"Affirmative. According to information hosted on clinicaltrials.gov, this experiment is actively seeking applicants and was initially posted on March 1st 2018; the listing has since been updated most recently on June 16th 2022. A total of 138 participants are requested from 9 different medical sites."

Answered by AI

In which geographical areas is this experiment accessible?

"The trial is being conducted at a variety of sites, including the UCSD Moores Cancer Center in La Jolla and Sanford Stem Cell Clinical Center at UCSD in New Hyde Park. Additionally, Northwell Health in New Haven as well as other medical hubs are also hosting this clinical study."

Answered by AI

What findings have been reported in studies conducted with Cirmtuzumab and ibrutinib?

"Cirmtuzumab plus ibrutinib was initially investigated in 2011 at the NIH Clinical Center, 9000 Rockville Pike. A total of 97 trials have been completed while 155 are still ongoing; many out of La Jolla and New york City."

Answered by AI

What are the key goals of this exploration?

"This medical trial sets out to measure the Complete Response Rate over 72 weeks following recruitment of the final subject. Secondary objectives involve changes in ROR1 cell surface expression and receptor occupancy, treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.03, and Time to Response (TTR)."

Answered by AI
Recent research and studies
~5 spots leftby Aug 2024