What side effects are associated with this type of intervention?

Common treatments for CD20+ B-cell malignancies, such as rituximab, obinutuzumab, and ofatumumab, often cause infusion-related reactions (fever, chills, hypotension), increased risk of infections, and hematologic toxicities like neutropenia and thrombocytopenia. Non-hematologic side effects can include fatigue, nausea, and diarrhea. Enhanced ADCC activity, as seen with ocaratuzumab, may also increase the risk of these adverse effects.

What prior FDA approvals exist?

Several FDA-approved drugs target CD20+ B-cell malignancies by enhancing ADCC. Rituximab, a chimeric monoclonal antibody, was one of the first to be approved and is widely used in combination with chemotherapy for various B-cell lymphomas. Obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, has also been approved and is known for its enhanced ADCC compared to rituximab. Ofatumumab, another fully human anti-CD20 monoclonal antibody, is approved for chronic lymphocytic leukemia (CLL) and also enhances ADCC. These drugs have set the precedent for targeting CD20 in B-cell malignancies, similar to the investigational drug ocaratuzumab.

What other types of research exist?

Promising alternatives to Ocaratuzumab for CD20+ B-cell malignancies include: 1) Obinutuzumab, which has shown efficacy in combination with other therapies in various studies. 2) Acalabrutinib, particularly in combination with Obinutuzumab, has demonstrated improved progression-free survival in clinical trials. 3) Ibrutinib, either alone or in combination with Rituximab, has shown significant efficacy in treating chronic lymphocytic leukemia and small lymphocytic lymphoma. These alternatives offer enhanced targeting and improved patient outcomes.

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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

Must not have

Women who are pregnant or breast-feeding

Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Ocaratuzumab, a protein that helps the immune system target and destroy certain cancer cells, in patients whose cancers have not responded to other treatments. The treatment works by marking cancer cells so the body's defense system can find and destroy them.

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.

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.

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 below

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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.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I am a woman able to have children and agree to use birth control during the study and for 6 months after.

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I have not received anti-CD20 therapy in the last 4 weeks.

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I do not have an ongoing severe infection requiring antibiotics.

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I am positive for hepatitis B, C, or HIV but not on HIV antiretroviral therapy.

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I do not have severe heart disease or unstable chest pain.

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I will not receive chemotherapy or drugs that weaken the immune system during the study.

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I haven't had chemotherapy or immunotherapy in the last 14 days.

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I am on a daily steroid treatment of 10 mg or more.

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

Awards & Highlights

No Placebo-Only Group

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

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for CD20+ B-cell malignancies involve monoclonal antibodies like ocaratuzumab, which target the CD20 surface marker on B lymphocytes. These antibodies work by binding to CD20, leading to direct cytotoxic effects, enhanced antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC). This targeted approach is significant for patients as it specifically attacks malignant B cells, reducing tumor burden and improving outcomes while minimizing damage to other cells.

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