Chemo-Free hope: new drug cocktail targets aggressive lymphoma
NCT ID NCT07231250
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase II trial is testing a combination of three drugs—glofitamab, polatuzumab vedotin, and zuberitamab—in 40 people newly diagnosed with diffuse large B-cell lymphoma. The goal is to see if this chemo-free approach can achieve complete remission early in treatment. Participants will receive the drugs intravenously over several cycles, with the main focus on how many achieve remission by the fourth cycle.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glofitamab, polatuzumab vedotin, and zuberitamab (drug combination)
- What this could lead to
- If successful, this could offer a chemotherapy-free treatment option for newly diagnosed diffuse large B-cell lymphoma, potentially improving remission rates.
- What could go wrong
- This is an early Phase II study with only 40 participants, so results may not apply to all patients. Side effects from the drug combination are possible and not yet fully known.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 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.
Inclusion Criteria: * The following criteria must be met to be eligible for the study: 1. Written informed consent. 2. Age ≥18 years at the time of signing the Informed Consent Form 3. IPI score 2-5. 4. ECOG performance status of 0-2. 5. Histologically confirmed CD20-positive LBCL, including one of the following diagnoses by 2022 WHO classification of lymphoid neoplasms: * DLBCL, not otherwise specified (NOS) including germinal B-cell type, activated B-cell type * T-cell/histiocyte-rich large B-cell lymphoma * Epstein-Barr virus-positive DLBCL, NOS * Anaplastic lymphoma kinasepositive large B-cell lymphoma * Kaposi's sarcomaassociated herpesvirus/human herpesvirus-8positive DLBCL * DLBCL/HGBCL with MYC and BCL2 rearrangements * HGBCL, NOS. (6) At least one measurable site of disease (\>1.5 cm long axis). (7) No previous treatment for lymphoma. (8) Life expectancy ≥6 months. (9) Left ventricular ejection fraction (LVEF) ≥50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) (10) Patient has adequate liver function: * Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert's syndrome). * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤3 x ULN. o Patients with documented liver involvement: AST and/or ALT ≤5 x ULN. (11) Patient has adequate hematological function, unless due to lymphoma: * Hemoglobin ≥9.0 g/dL within 7 days before the first treatment. * Absolute neutrophil count of ≥1.0 x 109 cells/L (1,000/μL). * Platelet count of ≥75 x 109 cells/L (75,000/μL). Note: Transfusion of RBCs and platelets is allowed to reach the inclusion criteria. In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the principal investigator. (12) Patient has adequate renal function: * Creatinine ≤ 1.5 x ULN, or Creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥ 30 mL/min for patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function. Exclusion Criteria: * Patients who meet at least one of the following criteria are not eligible for trial participation: 1. History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm). Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF \> 40%. 2. Patient with current or history of CNS lymphoma. 3. Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus \[EBV\], cytomegalovirus \[CMV\], hepatitis B, hepatitis C, and HIV\], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment. Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 4. Patient with current \> Grade 1 peripheral neuropathy. 5. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment 6. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study. 7. Known hypersensitivity to hamster ovary (CHO) cell products or to any component of the Zuberitamab, polatuzumab vedotin, obinutuzumab, or glofitamab and/or to the contrast agents used in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bispecific antibody are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug combo reach lymphoma hiding in the brain?
- Can a new drug combo boost remission in aggressive lymphoma?
- Can a Four-Pronged attack beat brain lymphoma?
- Can a new drug combo outsmart resistant lymphomas?
- Can a targeted drug boost standard chemo for aggressive lymphoma?
- Can a targeted drug combo outsmart an aggressive lymphoma?