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New drug combo targets Hard-to-Treat lymphomas

NCT ID NCT06137144

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests a new drug called AZD3470, alone or with pembrolizumab (Keytruda), in people with certain blood cancers like lymphoma. The goal is to check safety, side effects, and whether the drug shrinks tumors. About 161 adults and teens will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD3470 (a PRMT5 inhibitor) and pembrolizumab (Keytruda)
What this could lead to
If successful, this could point toward a new treatment option for certain blood cancers like lymphoma.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are unknown at this stage.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 161 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

May 2029

An estimate. End dates often move.

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

12 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Core Inclusion criteria: 1. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments 2. Adequate organ and bone marrow function. Module 1 Cohort 1: 1. Age: 1. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent. 2. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg. 2. Histologically confirmed diagnosis of cHL based on WHO criteria 3. Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r/r active disease requiring treatment. 4. Participants must provide FFPE baseline tumour tissue. 5. At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion ( \>1.5 cm for nodal lesion and \>1 cm for extranodal lesion). Module 1 Cohort 2: 1- Participants must be at least 50 years of age or older at study entry. 2- Histologically confirmed diagnosis of cHL based on WHO criteria 3- Ann Arbor stages III or IV. 4- Participant must have previously received at least 4 cycles of SoC combination therapy with A-AVD, N-AVD, AVD, or ABVD (based on regional SOC, per investigator) as finite first-line induction therapy, and achieved at least a PR post-induction therapy. 5- Participants must provide FFPE baseline tumour tissue. Module 1 Cohort 3: 1. Participants must be aged ≥ 18 years at the time of signing the informed consent. 2. Histologically confirmed diagnosis of PTCL NOS, systemic ALCL, or AITL based on WHO criteria. 2a- If pre-screening for MTAP deficiency is initiated, all participants must be MTAP deficient as determined by a local test. 3- Participants must have received at least 1 prior line of therapy for the treatment of PTCL and have exhausted all available therapies with demonstrated clinical benefit. Participants with ALCL must have received prior BV treatment. 4- Participants must provide FFPE baseline tumour tissue 1. Ability to provide an on-treatment biopsy (if the tumour is suitable for biopsy). 5- At least 1 radiographically measurable, and/or FDG-avid lymphoma lesions (\> 1.5 cm for nodal lesion and \>1 cm for extranodal lesion). Module 2 Cohort 1: 1- Participants must be aged ≥ 18 years at the time of signing the informed consent. 2- Histologically confirmed diagnosis of cHL based on WHO criteria 3- At least 1 radiographically measurable, and/or FDG-avid lymphoma lesions (\> 1.5 cm for nodal lesion and \>1 cm for extranodal lesion). 4- Participant must have received at least 1 prior line of therapy for the treatment of cHL and have documented r/r active disease requiring treatment. 5- Participants must provide FFPE baseline tumour tissue. Exclusion Criteria: Core Exclusion criteria: 1. Any significant laboratory finding or any severe and uncontrolled medical condition. 2. Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression. 3. Serologic active HBV or HCV infection. 4. Known to have tested positive for HIV. 5. Active gastrointestinal disease or other condition that will interfere with oral therapy. 6. Any of the following ECG cardiac criteria: Mean resting QTcF \> 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and/or any factors that increase the risk of QTc prolongation or risk of arrhythmic events. 7. Undergone any of the following procedures within 6 months prior to first dose: a) Coronary artery bypass graft, b) Percutaneous coronary intervention or heart valve replacement or repairment, c) Vascular stent implantation (venous stent is eligible), d) Acute coronary syndrome / myocardial infarction, e) Unstable or poorly controlled angina pectoris, f) Ventricular arrhythmias requiring continuous therapy, g) Uncontrolled atrial fibrillation, h) Haemorrhagic or thrombotic stroke (including transient ischaemic attacks) or any other CNS bleeding. i) Acute venous or atrial thromboembolic event (unless considered stable or adequately treated with at least 3months of therapeutic anticoagulation). 8. Severe valvular heart disease. 9. Congestive heart failure Grade II to Grade IV. 10. Prior or current cardiomyopathy. 11. Uncontrolled hypertension. 12. History of significant haemoptysis or haemorrhage within4 weeks of the first dose of study treatment. 13. Unresolved toxicities of Grade \> 1 from prior anti cancer therapy (excluding peripheral neuropathy, vitiligo, alopecia and endocrine disorders that are controlled with replacement hormone therapy, and asymptomatic laboratory abnormalities), unless immune-mediated. 14. History of another primary malignancy. 15. Received the following anticancer therapies: anti-lymphoma therapy (within 21 days), radiation therapy(within 28 days), allo-HSCT (within 180 days), auto-HSCT/cellular therapy (within 60 days), or MAT2A or PRMT5 inhibitor 16. Requires ongoing immunosuppressive therapy, including systemic corticosteroids. 17. Psychiatric illness/social situations/substance abuse disorders that would limit compliance with study requirements or compromise the ability to give written informed consent. 18. Use of prescription medications that are known as: 1. Strong or moderate inhibitors or inducers of CYP3A4, sensitive substrates of CYP3A4, inhibitors or substrates of CYP2D6, inhibitors and sensitive substrates of CYP2C8, and NTI substrates of CYP3A4, CYP2D6, and CYP2C8. 19. Received live, attenuated vaccine within 30 days prior to first dose of treatment. 20. Known hypersensitivity to AZD3470 or any of the excipients of the product. 21. Involvement in planning or conduct of the study (applies to both AstraZeneca staff and site staff). 22. Judgement by investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. 23. Previous enrolment in the present study. 24. Pregnant (confirmed with positive pregnancy test) or breastfeeding or intends to become pregnant during the study. 25. Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study. Module 2 Cohort 1: <!-- --> 1. History of confirmed ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment or any evidence of clinically active ILD or pneumonitis. 2. ≥Grade 3 immune-mediated AE while receiving prior checkpoint inhibitor immunotherapy, or any unresolved ≥Grade 2 immune-mediated AE. 3. History of immune-mediated myocarditis or pericarditis. 4. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. 5. Active or prior documented pathologically confirmed autoimmune or inflammatory disorders 6. Refractory to prior checkpoint inhibitor therapy (within 12 weeks of last dose) 7. Eligible for allogeneic or autologous stem cell transplant. 8. Received an allogeneic HSCT within 5 years of the first dose of study treatment; must not have active Graft-versus-host disease. 9. Participants with a known hypersensitivity to pembrolizumab or any of the excipients of the product.

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma classic Hodgkin lymphoma Hodgkins lymphoma lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma non-Hodgkin lymphoma peripheral T-cell lymphoma, not otherwise specified

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AITL ALCL Hodgkin lymphoma Lymphoma Non-Hodgkin lymphoma Peripheral T-cell lymphoma (PTCL) PTCL-nos

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Locations

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33136, United States

  • Research Site

    WITHDRAWN

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    RECRUITING

    New York, New York, 10016, United States

  • Research Site

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    WITHDRAWN

    Adelaide, 5000, Australia

  • Research Site

    WITHDRAWN

    Birtinya, 4575, Australia

  • Research Site

    NOT_YET_RECRUITING

    Fitzroy, 3065, Australia

  • Research Site

    RECRUITING

    Nedlands, 6009, Australia

  • Research Site

    WITHDRAWN

    South Brisbane, 4101, Australia

  • Research Site

    WITHDRAWN

    Waratah, 2298, Australia

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 01401-002, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 05652-900, Brazil

  • Research Site

    RECRUITING

    Beijing, 100191, China

  • Research Site

    RECRUITING

    Guangzhou, 510060, China

  • Research Site

    RECRUITING

    Shanghai, 20032, China

  • Research Site

    TERMINATED

    Créteil, 94010, France

  • Research Site

    RECRUITING

    Dijon, 21079, France

  • Research Site

    RECRUITING

    Lille, 59000, France

  • Research Site

    RECRUITING

    Pierre-Bénite, 69310, France

  • Research Site

    RECRUITING

    Villejuif, 94805, France

  • Research Site

    NOT_YET_RECRUITING

    Berlin, 12203, Germany

  • Research Site

    RECRUITING

    Cologne, 50937, Germany

  • Research Site

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Research Site

    NOT_YET_RECRUITING

    Würzburg, 97080, Germany

  • Research Site

    RECRUITING

    Alessandria, 15100, Italy

  • Research Site

    RECRUITING

    Bologna, 40138, Italy

  • Research Site

    RECRUITING

    Milan, 20141, Italy

  • Research Site

    RECRUITING

    Bunkyō City, 113-8677, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    RECRUITING

    Madrid, 28041, Spain

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Research Site

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.