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Monoclonal Antibodies
Ocaratuzumab for B-Cell Cancer
Phase 1
Waitlist Available
Research Sponsored by Mentrik Biotech, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of a CD20+ B-cell malignancy
Age >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every office visit throughout the study for up to 12 months
Awards & highlights
Study Summary
This trial is a phase I study of ocaratuzumab, a monoclonal antibody that targets the CD20 surface marker on normal and malignant B lymphocytes. The trial will investigate the safety and tolerability of three different doses of ocaratuzumab administered subcutaneously to patients with previously treated CD20+ B-cell malignancies.
Who is the study for?
Adults over 18 with CD20+ B-cell malignancies who've had at least one prior treatment can join. They must have good liver, kidney, and blood function, not be on high-dose steroids or have hepatitis B/C or HIV. Pregnant women and those with severe heart disease or infections are excluded.Check my eligibility
What is being tested?
The trial tests subcutaneous Ocaratuzumab in three doses for safety and effectiveness in patients previously treated for B-cell malignancies. It's a phase I study focusing on how the body reacts to different dosages of this antibody therapy.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms, fatigue, nausea, and increased risk of infection due to immune system suppression. Specific side effects will be monitored closely given it is an early-phase trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of B-cell malignancy that tests positive for CD20.
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I am older than 18 years.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every office visit throughout the study for up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every office visit throughout the study for up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacodynamic profile of B-cell depletion and re-population as measured by CD19+ peripheral blood B lymphocyte count
Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life
Secondary outcome measures
Immunogenicity as measured by the incidence, titre of human anti-human antibody (HAHA) immune response
Anniversary Reaction
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
SC ocaratuzumab 80 mg weekly x 8 doses
Group II: Cohort 2Experimental Treatment1 Intervention
SC ocaratuzumab 80 mg weekly x 4 doses
Group III: Cohort 1Experimental Treatment1 Intervention
SC ocaratuzumab 40 mg weekly x 4 doses
Find a Location
Who is running the clinical trial?
Mentrik Biotech, LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to similar drugs or substances in the past.I do not have severe heart disease or unstable chest pain.You have a mental health condition or social circumstances that may make it difficult for you to follow the study rules.I am not pregnant or breastfeeding.I am a woman able to have children and agree to use birth control during the study and for 6 months after.I am eligible for treatment with the study drug alone.I do not have an ongoing severe infection requiring antibiotics.I am positive for hepatitis B, C, or HIV but not on HIV antiretroviral therapy.I have not received anti-CD20 therapy in the last 4 weeks.I will not receive chemotherapy or drugs that weaken the immune system during the study.My blood, kidney, and liver functions are all within normal ranges.I haven't had chemotherapy or immunotherapy in the last 14 days.My cancer is a type of B-cell malignancy that tests positive for CD20.I am on a daily steroid treatment of 10 mg or more.I have had at least one treatment before and my cancer was CD20 positive.You are expected to live for at least 6 more months.I am older than 18 years.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA greenlit ocaratuzumab for general use?
"Our research team at Power judged ocaratuzumab's safety to be a 1, given that this is an initial-phase trial with limited data backing its efficacy and security."
Answered by AI
Are there currently any enrollment opportunities for this trial?
"According to clinicaltrials.gov, this medical trial is not currently recruiting patients but was first posted on January 1st 2015 and last updated two years prior in February 2014. However, there are 2,379 other studies hoping to enroll participants at the present moment."
Answered by AI
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