New combo therapy hopes to tackle tough lymphoma
NCT ID NCT03533283
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This trial tests two new drug combinations (glofitamab plus atezolizumab or polatuzumab vedotin) in adults with B-cell non-Hodgkin lymphoma that has returned or not responded to prior treatment. The study aims to find the safest dose and see if these combos shrink tumors. About 211 participants will receive the drugs intravenously over several cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glofitamab, atezolizumab, polatuzumab vedotin, obinutuzumab
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat B-cell non-Hodgkin lymphoma, potentially improving response rates.
- What could go wrong
- This is an early-phase trial (phase 1/2) with a small number of participants, so results may not apply broadly. Side effects from the drug combinations could be significant.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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211 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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Oct 2026
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.
Main Inclusion Criteria * Histologically-confirmed hematologic malignancy that is expected to express CD20 (Relapsed after or refractory to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival or patients refusing chemotherapy or autologous stem cell transplant (SCT)) * Dose-escalation: Grades 1-3b relapsed or refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL) (nodal; extra-nodal; or splenic), diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 rearrangements (double-hit lymphoma), HGBCL not otherwise specified (NOS), DLBCL arising from FL (transformed FL) * Dose-expansion: R/R LBCL, including DLBCL NOS, DLBCL arising from FL (transformed FL), PMBCL, HGBCL with MYC and BCL2 and/or BCL6 rearrangements (i.e., double-hit and triple-hit lymphomas), and HGBCL NOS * At least one measurable target lesion * Fresh pre-treatment biopsy, but if this cannot be taken, a previous archived biopsy from metastatic lesion can be taken as replacement if it is not older than 6 months and not confounded by major events (progression, treatment) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Adequate organ function (liver, hematological, renal) * Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) Inclusion Criteria Specific to Imaging Substudy * At least two measurable target lesions * Able to provide two fresh tumor biopsies (baseline and on-treatment) Main Exclusion Criteria * Participants with Chronic Lymphocytic Leukemia (CLL), acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Richter's transformation, CD20-positive ALL, Burkitt lymphoma, or lymphoplasmacytic lymphoma * Current \> Grade 1 peripheral neuropathy (only for participants being treated in the polatuzumab vedotin arm) * Patients with known active infection, or reactivation of a latent infection within 4 weeks prior to Obinutuzumab (Gpt) infusion * Patient with history of confirmed progressive multifocal leukoencephalopathy (PML) * History of leptomeningeal disease * Current or past history of central nervous system (CNS) lymphoma * Current or past history of CNS disease * Major surgery or significant traumatic injury \</=28 days prior to Gpt infusion * Significant cardiovascular disease or significant pulmonary disease * Active or history of autoimmune disease or immune deficiency (with exceptions, e.g. hypothyroidism and Diabetes mellitus Type 1) * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy within 4 weeks prior to Gpt infusion * Prior solid organ transplantation * Prior allogenic stem cell transplant (SCT) * Autologous SCT within 100 days prior to Gpt infusion * Documented refractoriness to an obinutuzumab-monotherapy regimen * Prior treatment with anti-cancer/lymphoma therapies and systemic immunotherapeutic/immunostimulating agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Gpt infusion * Any history of immune related \>/= Grade 3 adverse events (AE) with the exception of endocrinopathy managed with replacement therapy * Ongoing corticosteroid use \>25 milligrams/day of prednisone or equivalent within 4 weeks prior to and during study treatment * Treatment with systemic immunosuppressive medication * Administration of a live, attenuated vaccine within 4 weeks prior to Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment Exclusion Criteria Specific to Imaging Substudy * Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count and/or the presence of abnormal/malignant cells in the peripheral blood differential signifying circulating lymphoma cell * Participants who have had splenectomy or functional asplenia that could compromise protocol objectives
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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
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Aarhus Universitetshospital Skejby
Aarhus N, 8200, Denmark
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Asst Papa Giovanni Xxiii
Bergamo, Lombardy, 24127, Italy
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Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
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Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, 20133, Italy
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Hadassah Ein Karem Hospital
Jerusalem, 9112001, Israel
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Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Duran i Reynals
Barcelona, 08907, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
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Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Naples, Campania, 80131, Italy
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Odense Universitetshospital
Odense C, 5000, Denmark
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Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, 40138, Italy
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Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
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Rigshospitalet
København Ø, 2100, Denmark
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START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040, Spain
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The HOPE Clinical Trials Unit
Leicester, LE1 5WW, United Kingdom
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The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
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UZ Gent
Ghent, 9000, Belgium
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University College London Hospitals NHS Foundation Trust
London, W1T 7HA, United Kingdom
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