New pill targets Hard-to-Treat lymphoma in first human trial
NCT ID NCT06393738
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This early-stage trial tests an experimental drug called ARV-393 in 255 adults with advanced non-Hodgkin's lymphoma that has come back or not responded to other treatments. The drug is taken as a pill and works by breaking down a protein that helps lymphoma grow. The main goals are to check safety and find the right dose, while also seeing if it can shrink tumors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 329 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 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.
Inclusion Criteria: * For Part A and B: Have relapsed/refractory NHL and \>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy. * For Part C and D: Have R/R DLBCL, not otherwise specified \[NOS (DLBCL, NOS)\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy. * Have at least one bi dimensionally measurable lesion \>1.5-centimeter (cm) in largest dimension for nodal or \>1.0 cm for extranodal lesion. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma). * Adequate bone marrow function * Adequate kidney function * Adequate Liver Function Exclusion Criteria: * Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS), except for peripheral eosinophilia due to disease under study. Participants with current or prior eosinophilia requiring systemic steroid treatment are excluded regardless of etiology. * Prior allogeneic stem cell transplant (SCT) or solid organ transplantation. * Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 60 days prior to Cycle 1 Day 1 (C1D1) or any prior treatment with a BCL6-targeted therapy * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance. * Any of the following in the previous 6 months: * Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes; * Clinically important atrial or ventricular arrhythmias; * Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV; * Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease; * Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery. * Uncontrolled hypertension despite optimal medical treatment * History of myocarditis. * In ability to comply with listed prohibited treatments. * Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. * Cardiac ejection fraction \<45%.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
20 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Clinical Trial SIte
RECRUITINGEast Melbourne, Victoria, 3002, Australia
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Clinical Trial SIte
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Clinical Trial Site
RECRUITINGNew Haven, Connecticut, 06510, United States
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Clinical Trial Site
RECRUITINGMiami, Florida, 33136, United States
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Clinical Trial Site
RECRUITINGDetroit, Michigan, 48201, United States
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Clinical Trial Site
RECRUITINGNew Brunswick, New Jersey, 10065, United States
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Clinical Trial Site
RECRUITINGNew York, New York, 10016, United States
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Clinical Trial Site
RECRUITINGNew York, New York, 10021, United States
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Clinical Trial Site
RECRUITINGCleveland, Ohio, 44122, United States
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Clinical Trial Site
WITHDRAWNNashville, Tennessee, 37203, United States
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Clinical Trial Site
RECRUITINGHouston, Texas, 77030, United States
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Clinical Trial Site
RECRUITINGCharlottesville, Virginia, 22908, United States
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Clinical Trial Site
RECRUITINGToronto, Ontario, M5G 1Z5, Canada
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Clinical Trial Site
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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Clinical Trial Site
RECRUITINGCopenhagen, 2100, Denmark
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Clinical Trial Site
RECRUITINGOdense C, 5000, Denmark
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Clinical Trial Site
RECRUITINGEl Palmar, Murcia, 30120, Spain
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Clinical Trial Site
RECRUITINGPamplona, Navarre, 31008, Spain
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Clinical Trial Site
RECRUITINGBarcelona, 8908, Spain
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Clinical Trial Site
RECRUITINGMadrid, 28050, Spain
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Clinical Trial Site
RECRUITINGSalamanca, 37007, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug combo outperform standard chemo for Hard-to-Treat lymphoma?
- Can immune cells plus a checkpoint drug outsmart lymphoma?
- Can a cancer biopsy predict who responds to a new immunotherapy?
- Can a reshaped chemo combo tame lymphoma with fewer side effects?
- Can a cancer drug reboot the immune system after a stem cell transplant?