GEN3017 for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GEN3017 for individuals with certain types of lymphoma that have returned or do not respond to other treatments. The main goal is to determine the safety and effectiveness of GEN3017 against these lymphomas. The treatment is administered through injections, and all participants will receive the active drug, not a placebo. It is suitable for those with relapsed or refractory CD30-positive lymphomas (a type of cancer where specific proteins are present in tumor cells) who have tried at least two other treatments without success. As a Phase 1 trial, this research aims to understand how GEN3017 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop all current medications, but you cannot have had chemotherapy within 2 weeks, major surgery within 4 weeks, or be on certain immunosuppressive drugs or high-dose corticosteroids within 14 days before starting the trial.
Is there any evidence suggesting that GEN3017 is likely to be safe for humans?
Research shows that GEN3017 is being tested for safety and effectiveness in treating certain blood cancers, including some lymphomas that have returned or are not responding to treatment. Previous studies indicated that GEN3017 is safe enough to continue testing. Data from other treatments targeting CD30, a protein found on some cancer cells, generally support this conclusion, as they have been well-tolerated.
Although earlier studies lack specific data on GEN3017's safety in humans, current trials suggest it is safe enough for human testing. These trials are in the early stages, indicating the treatment has passed initial safety checks, but further testing is needed to confirm its safety and effectiveness. Participants should remember that all treatments can have side effects, but GEN3017 has shown promise in progressing through the safety evaluation process.12345Why do researchers think this study treatment might be promising for lymphoma?
GEN3017 is unique because it targets CD30, a protein often found on certain lymphoma cells, offering a more precise attack on cancer compared to standard chemotherapy, which affects both cancerous and healthy cells. This precision could mean fewer side effects and better outcomes for patients with relapsed or refractory CD30-positive Hodgkin's lymphoma and T-cell lymphoma. Researchers are excited because this targeted approach may provide a new option for patients who have not responded well to existing treatments like brentuximab vedotin or traditional chemotherapy.
What evidence suggests that GEN3017 might be an effective treatment for lymphoma?
This trial will evaluate GEN3017 for its effectiveness in treating lymphoma. Research has shown that GEN3017 targets CD30, a marker found on some lymphoma cells. In earlier studies, patients with relapsed or hard-to-treat CD30-expressing lymphomas responded well to similar treatments targeting CD30. This suggests GEN3017 could help shrink lymphoma tumors by focusing on these specific cancer cells. Initial results from other trials showed promising anti-tumor effects, indicating its potential effectiveness. While more data is needed to confirm these findings, the treatment's design offers hope for those with difficult-to-treat lymphomas.678910
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
This trial is for adults with relapsed or refractory CD30-expressing Hodgkin and Non-Hodgkin Lymphomas, who have at least one measurable lesion. Participants should be in good physical condition (ECOG score 0-1) and not have received certain recent treatments like chemotherapy, major surgery, or investigational drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Evaluation of dose-limiting toxicities to determine the recommended phase 2 dose and maximum tolerated dose for relapsed or refractory CD30+ lymphomas
Expansion
Assessment of anti-tumor activity, safety, immunogenicity, pharmacokinetics, and pharmacodynamics at the recommended phase 2 dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GEN3017
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen