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A Study of ARV-393 for Relapsed/Refractory Non-Hodgkin Lymphoma

This study is investigating ARV-393, a new oral drug, for people with advanced non-Hodgkin lymphoma (NHL) that has come back or not responded to previous treatments (relapsed/refractory). It's also for those with a specific type called Angioimmunoblastic T-cell Lymphoma (AITL). ARV-393 is thought to work by breaking down a protein that helps NHL tumors grow. This is the first time ARV-393 is being used in people. The study will look at the safety of ARV-393 alone and in combination with another drug called glofitamab. To join, you must be at least 18 years old and have received at least two prior treatments for your NHL, or have AITL that has returned or worsened after standard care. The study aims to see how safe ARV-393 is and if it can help shrink tumors.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It will involve up to 255 participants and is designed to find the best dose of ARV-393 alone and with glofitamab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for 30 to 40 days after your last dose of ARV-393, depending on which part of the study you are in.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06393738

A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Arvinas Inc.
~329 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:ARV-393Glofitamab

At a glance

Recruiting sites
18 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities During First 28 Days
Measured over 28 days from first study dosing
+3 more outcomes measured

Conditions

Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

Explore related trials

Diffuse Large B-Cell LymphomaFollicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypeLarge B-cell lymphomaNon-Hodgkin Lymphoma

Where it's being run

19 sites across 15 states
Spain3
New York2
Denmark2
Connecticut1
Florida1
Michigan1
New Jersey1
Ohio1

Who to contact

Arvinas Operations, Inc.
[email protected]
475-345-0791
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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%.

What this trial measures

  • Incidence of Dose Limiting Toxicities During First 28 Days28 days from first study dosing

    Percentage of participants in dose escalation arm at a given dose cohort with AEs meeting protocol defined dose limiting toxicities during cycle 1 (28 days)

  • Percentage of Participants With Adverse Events Characterized by Severity, Seriousness, and Relationship to Study Drug as a Measure of Safety and TolerabilityParts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393

    Adverse events as characterized by type, frequency, severity, seriousness, and relationship to study drug

  • Number of Participants With Abnormal Vital Signs, Abnormal ECG Readings (QT Interval) and Abnormal Laboratory ParametersParts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393

    Shifts in vital signs, ECGs, and laboratory parameters from study baseline

  • Percentage of Participants With Grade 3 or Grade 4 Clinical Lab Abnormalities Using the Common Terminology Criteria for Adverse Events (CTCAE) With Scale From Grade 1 Grade 5. Higher Score Means Worse OutcomeParts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393

    Incidence of Grade 3 and Grade 4 clinical laboratory abnormalities