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New immunotherapy MK-1045 takes on tough lymphomas

NCT ID NCT07519772

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 16 times

Summary

This study tests an experimental immunotherapy called MK-1045 in 200 people with two types of non-Hodgkin lymphoma: follicular lymphoma (slow-growing) and diffuse large B-cell lymphoma (fast-growing). Participants have already tried at least two other treatments without success. The trial aims to see if MK-1045 is safe and whether it can shrink or eliminate tumors.

What this could mean

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

Active substance
MK-1045 (also called CN-201), an immunotherapy drug given by IV or injection
What this could lead to
If successful, MK-1045 could offer a new treatment option for people with certain types of non-Hodgkin lymphoma that have not responded to prior therapies.
What could go wrong
This is an early-phase trial (1b/2) with only 200 participants, so results may not apply to everyone. The main focus is safety, and it is not yet known if MK-1045 will shrink tumors or improve survival.

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 280 people

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

Started

May 2026

Expected to finish

Apr 2031

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

18 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: The main inclusion criteria include but are not limited to the following: * Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy. * Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). * DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy. * Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care). * Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy. * Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection. * Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. * Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection. * Has radiographically measurable disease per Lugano Response Criteria. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has received a solid organ transplant. * Had or has clinically relevant central nervous system (CNS) diseases. * Has a history of serious cardiovascular or cerebrovascular diseases. * Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received a live or live-attenuated vaccine within 30 days of randomization. * Has received prior CAR-T therapy within 3 months before the first dose of the study intervention. * Has a known additional malignancy that is progressing or required active treatment within the past 2 years. * Has known active CNS lymphoma or involvement. * Has active autoimmune disease that required systemic treatment in the past 2 years. * Has active infection requiring systemic therapy. * Has a history of severe bleeding disorders. * Has not recovered from major surgery or has ongoing surgical complications. * Has diagnosis of primary mediastinal B-cell lymphoma.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma, follicular Lymphoma, large B-cell, diffuse Lymphoma, non-Hodgkin

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites in 14 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Antalya Egitim ve Arastirma Hastanesi ( Site 1003)

    RECRUITING

    Antalya, 7100, Turkey (Türkiye)

  • Beijing Cancer hospital ( Site 1701)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Box Hill Hospital ( Site 0202)

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Carmel Hospital ( Site 0602)

    RECRUITING

    Haifa, 3436212, Israel

  • Clínica Alemana de Santiago ( Site 1608)

    RECRUITING

    Santiago, Region M. de Santiago, 7650568, Chile

  • Colorado Blood Cancer Institute ( Site 7000)

    RECRUITING

    Denver, Colorado, 80218, United States

  • Derriford Hospital ( Site 1304)

    RECRUITING

    Plymouth, Devon, Pl6 8DH, United Kingdom

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)

    RECRUITING

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer Center ( Site 1711)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Haddasah Medical Center ( Site 0600)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Aleman ( Site 1400)

    RECRUITING

    CABA, C1118AAT, Argentina

  • Hospital Universitari Vall de Hebron ( Site 1102)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 1105)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Austral ( Site 1402)

    RECRUITING

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Hospital Universitario Gregorio Maranon ( Site 1101)

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Virgen de la Victoria ( Site 1104)

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)

    RECRUITING

    Candiolo, Piedmont, 10060, Italy

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Instituto Alexander Fleming ( Site 1404)

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Istituto Europeo di Oncologia IRCCS ( Site 0702)

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700)

    RECRUITING

    Campania, Napoli, 80131, Italy

  • Koç Üniversitesi Hastanesi ( Site 1001)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Medipol Mega Universite Hastanesi ( Site 1002)

    RECRUITING

    Istanbul, 34214, Turkey (Türkiye)

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Pratia MCM Krakow ( Site 0903)

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Pratia Onkologia Katowice ( Site 0902)

    RECRUITING

    Katowice, Silesian Voivodeship, 40-519, Poland

  • Princess Margaret Cancer Centre ( Site 0301)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • SCRI Oncology Partners ( Site 0100)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 1005)

    RECRUITING

    Samsun, 55270, Turkey (Türkiye)

  • Sanatorio Nuestra Senora del Rosario ( Site 1403)

    RECRUITING

    Rosario, Santa Fe Province, 2001, Argentina

  • Seoul National University Hospital ( Site 0800)

    RECRUITING

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center ( Site 0603)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center ( Site 0601)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center. ( Site 0604)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Sun Yat-Sen University Cancer Center ( Site 1712)

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801)

    RECRUITING

    Seoul, 07345, South Korea

  • The Christie NHS Foundation Trust ( Site 1300)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Townsville University Hospital ( Site 0204)

    RECRUITING

    Townsville, Queensland, 4814, Australia

  • UKGM Gießen/Marburg ( Site 0505)

    RECRUITING

    Giessen, Hesse, 35392, Germany

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