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New cocktail of cancer drugs shows promise in early lymphoma trial

NCT ID NCT05169515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 18, 2026 · Updated 7 times

Summary

This early-stage trial is testing whether combining two existing immunotherapy drugs (mosunetuzumab or glofitamab) with newer oral drugs (iberdomide and/or golcadomide) can safely treat B-cell non-Hodgkin lymphoma that has come back or not responded to previous treatments. About 121 adults with this type of blood cancer will receive these drug combinations to see if they shrink tumors and how well patients tolerate them. The goal is to find better options for people who have run out of standard treatments.

What this could mean

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

Active substance
mosunetuzumab, glofitamab, iberdomide, golcadomide
What this could lead to
If successful, this could lead to more effective treatment options for people with B-cell non-Hodgkin lymphoma that has not responded to prior therapies.
What could go wrong
This is an early phase 1 trial with a small number of participants, so safety and effectiveness are not yet proven. The drug combinations may cause significant side effects or fail to improve outcomes.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 121 people

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

Started

Oct 2022

Expected to finish

Aug 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

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: * Age \>/= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBCL/transformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen. * Participants with DLBCL/transformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol * Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma) * At least one bi-dimensionally measurable nodal lesion (\> 1.5 cm in its largest dimension by diagnostic quality CT or PET/CT scan), or at least one bi-dimensionally measurable extranodal lesion (\> 1.0 cm in its largest dimension by diagnostic quality CT or PET/CT scan) * Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of NHL * A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred * Adequate hematologic function without growth factors or blood product transfusion within 14 days of first dose of study drug administration * Normal laboratory values * All participants and health care providers will be trained and counseled on pregnancy prevention. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 3 months after the final dose of mosunetuzumab, at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC-99282, 3 months after the last dose of tocilizumab (if applicable), whichever is longer * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer Exclusion Criteria: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment) or within 3 months after the final dose of mosunetuzumab, at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, whichever is longer, 28 days after the last dose of CC-220, 28 days after the last dose of CC-9282, 3 months after the final dose of tocilizumab, whichever is longer * Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122, pomalidomide) \</= 4 weeks prior to starting CC-220 and/or CC-99282 * Inability to swallow pills, or persistent diarrhea or malabsorption \>= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management * QTc interval of \> 470 ms * The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation * Treatments (investigational or approved) within the following time periods prior to initiation/first dose of study treatment: radiotherapy within 2 weeks; autologous SCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days; prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugates within 4 weeks; use of radioimmunoconjugates within 12 weeks; systemic immunosuppressive medications within 2 weeks; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter * Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment * Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Major surgery or significant traumatic injury \< 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during study treatment * Clinically significant toxicities from prior treatment have not resolved to Grade \</= 1 (per US national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0) prior to the first study drug administration with exceptions defined by the protocol * Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary, liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliance with the protocol or interpretation of results * For participants enrolled into glofitamab cohort: documented refractoriness to an obinutuzumab monotherapy-containing regimen (defined as disease that did not achieve response (PR or CR) or progressed within 6 months of the last dose of an obinutuzumab-containing regimen)

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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

  • Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia

    Pisa, Piedmont, 56126, Italy

  • Center Hospital

    Ramat Gan, 5262199, Israel

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027, Spain

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Hosp Universitario Salamanca

    Salamanca, 37007, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28040, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026, Spain

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, Emilia-Romagna, 40138, Italy

  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

    Meldola, Emilia-Romagna, 47014, Italy

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN, United Kingdom

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB, United Kingdom

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Rambam Health Care Campus

    Haifa, 3109600, Israel

  • Soroka

    Beersheba, 0084101, Israel

  • Sourasky Medical Center

    Tel Aviv, 6423900, Israel

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program

    San Francisco, California, 94143, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University College London Hospitals

    London, W1T 7HA, United Kingdom

  • University of Colorado

    Aurora, Colorado, 80045, United States

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