What side effects are associated with this type of intervention?

Common treatments for lymphoma, such as chemotherapy and monoclonal antibodies, often have a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infections due to lowered white blood cell counts. Specific agents like rituximab, a monoclonal antibody, can lead to infusion reactions, including fever, chills, and low blood pressure, particularly during the first cycle. Long-term side effects may include neuropathy and cardiac issues. These side effects are similar to those observed in treatments for solid tumors, such as those being studied in the DZ-002 trial.

What prior FDA approvals exist?

Several FDA-approved treatments for lymphoma include monoclonal antibodies and combination therapies. Rituximab, an anti-CD20 monoclonal antibody, is commonly used in various lymphoma treatments. Other monoclonal antibodies like ofatumumab and obinutuzumab have also been approved for lymphoma. Additionally, combination therapies such as bendamustine plus rituximab (BR) are frequently used. These treatments focus on targeting specific proteins on cancer cells, similar to the targeted approach of DZ-002 in solid tumors.

What other types of research exist?

Promising novel alternatives to DZ-002 for lymphoma patients in 2024 include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory lymphoma. 2) Bispecific antibodies like mosunetuzumab and glofitamab, which target CD20 and CD3, offering a novel mechanism of action. 3) Antibody-drug conjugates such as polatuzumab vedotin, which combines a monoclonal antibody with a cytotoxic agent to target cancer cells more effectively.

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DZ-002 for Cancer

Phase 1

Recruiting

Research Sponsored by Da Zen Theranostics Inc

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests DZ-002, a new drug for cancer patients whose standard treatments didn't work. It involves regular IV doses to check safety, body behavior, and tumor effects.

Who is the study for?

Adults with advanced solid tumors or lymphoma that haven't responded to standard treatments can join this trial. They must be able to follow the study plan, have a life expectancy over 8 weeks, and good organ function. Women of childbearing age need a negative pregnancy test and agree to use birth control.

What is being tested?

The study is testing DZ-002's safety and finding the highest dose patients can take without serious side effects (MTD). It also aims to find the best dose for future studies (RP2D) while checking how the body processes it and its effectiveness against tumors.

What are the potential side effects?

Possible side effects of DZ-002 are not detailed in this summary but typically include reactions at injection sites, fatigue, nausea, liver issues, blood count changes, or allergic responses based on similar cancer drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and severity of treatment emergent adverse events (TEAEs)

MTD

Secondary study objectives

AUC

Clearance

Cmax

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalation and cohort expansion Q1WExperimental Treatment1 Intervention

DZ-002 treatment once every week

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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

Common treatments for lymphoma include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy, such as checkpoint inhibitors, enhances the body's immune response against cancer cells. Targeted therapies, like monoclonal antibodies, specifically target cancer cell markers, minimizing damage to normal cells. Understanding these mechanisms helps lymphoma patients and their doctors choose the most effective treatment with manageable side effects, improving outcomes and quality of life.

[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].