New shot for tough lymphomas shows early promise but trial halted
NCT ID NCT06018129
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new drug called GEN3017 in 9 people with CD30-positive lymphomas (Hodgkin and non-Hodgkin) that had returned or stopped responding to standard treatments. The drug was given as a shot under the skin. The main goals were to check safety and find the right dose. The trial was terminated early, so we have limited information on how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GEN3017 (a bispecific antibody that targets CD3 and CD30, given as a shot under the skin)
- What this could lead to
- If successful, this could point toward a new treatment option for people with certain lymphomas that have not responded to other therapies.
- What could go wrong
- This was a very early (phase 1/2a) trial that was terminated after only 9 participants, so results are limited. The drug may cause serious side effects like cytokine release syndrome or nerve toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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9 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Feb 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: Dose Escalation Part: 1. Must be at least 18 years of age. For participants in the R/R cHL Cohort in the United States (US) and Australia, must be at least 16 years of age. 2. Histologically confirmed R/R cHL or R/R TCL. 3. Participants must have at least 1 measurable lesion by fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or magnetic resonance imaging (MRI)-defined anatomical tumor sites and a CT scan (or MRI) with involvement of ≥1 measurable nodal lesion and/or ≥1 measurable extranodal lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 for participants 18 years of age and above. For participants ≥16 and \<18 years of age (US and Australia only), Karnofsky score of \>60% per Karnofsky performance scale. 5. Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017. 6. R/R cHL Cohort: * Must have relapsed or progressive cHL after receiving at least 2 or 3 prior lines of therapy; OR * Refractory to the second line of therapy. Key Exclusion Criteria: 1. Primary central nervous system (CNS) tumor or known CNS involvement. 2. Received prior investigational CD30-targeting therapy (except brentuximab vedotin). 3. Autologous hematopoietic stem cell transplant (HSCT) within 60 days (applies to both cHL and TCL). Allogeneic HSCT within 90 days (applies to cHL) prior to the first dose of GEN3017. 4. Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of GEN3017. 5. Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN3017. 6. Treatment with an investigational drug within 4 weeks or 5 half-lives of the drug, whichever is shorter prior to the first dose of GEN3017 or currently receiving any other investigational agents. 7. Prior treatment with live, attenuated vaccines within 30 days prior to the first dose of GEN3017. 8. Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at doses \>25 milligrams (mg) daily or its equivalent within 14 days prior to the first dose of GEN3017. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Helford Clinical Research Hospital
Duarte, California, 91010, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Patient's own t cells engineered to hunt lymphoma in early trial
- Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
- Immunotherapy injection tested against Hard-to-Treat childhood lymphoma
- Vaccine aims to train immune system against blood cancers
- Can a new pill boost Immunotherapy's power against advanced tumors?