Can a drug duo outsmart returning lymphoma?
NCT ID NCT06570447
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining two drugs—glofitamab and chidamide—can help people with diffuse large B-cell lymphoma that has come back or not responded to earlier treatment. The study will enroll about 22 adults and measure how many achieve a complete response (no detectable cancer) after treatment. The goal is to see if this combination is both effective and safe for this challenging situation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- glofitamab combined with chidamide
- What this could lead to
- If this combination works, it could offer a new treatment option for people with diffuse large B-cell lymphoma that has returned or not responded to prior therapy.
- What could go wrong
- This is a small, early-phase study (22 participants) without a comparison group, so results may not be conclusive. The combination may cause side effects, and its effectiveness is not yet proven.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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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.
Inclusion Criteria: \- To be eligible for enrollment in this study, a subject must meet all of the following criteria: 1. Signed informed consent 2. Age ≥ 18 years at the time of informed consent 3. Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures. 4. Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL) \- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed). 5. Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy). * Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy. * CAR T cells plus bridging were counted as a treatment line. * Local therapies (e.g., radiotherapy) will not be considered as treatment lines. 6. Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as \> 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as \> 1.0 cm in the longest diameter. 7. Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are acceptable. 8. Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1 9. Life expectancy (as assessed by the investigator) ≥ 12 weeks 10. Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia). 11. Adequate liver function * Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin; * AST/ALT ≤ 3 × ULN 12. Adequate hematological function: * Neutrophil count ≥ 1.5 x 109 cells/L (1.500/μL); * Platelet count ≥ 75,000/μL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1); * Haemoglobin ≥ 10.0 g/dL (6.2 mmol/L); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1 13. Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected by Serum creatinine levels as judged by the investigator) 14. Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of non-therapeutic Surgery) or Pregnancy test sterilized (absence of ovaries and/or uterus). For women of childbearing potential: Agree to remain abstinent (avoid heterosexual intercourse) or to take Contraception measures. 15. For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception Exclusion Criteria: Any subject who meets any of the following criteria should not be enrolled in the study: 1. Inability to comply with protocol-specified hospitalization and restrictions 2. Richter's transformation 3. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations 4. Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay) 5. Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen \[HBsAg\] serology). \- Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody \[HBcAb\] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy. 6. Positive Hepatitis C virus (HCV) Antibody test \- Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA. 7. Known HIV seropositive status \- For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations. 8. Known or suspected chronic active Epstein-Barr Viral infection 9. Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH) 10. Pregnancy or lactating, or planning to Pregnancy during treatment and for at least 3 months after the last dose of Gpt or within 2 months after the last dose of Glofitamab 11. A history of treatment-emergent Immunization related Immunization associated with prior Adverse event treatment agents as follows: * Grade 3 Adverse event, except for Grade 3 endocrinopathy managed with alternative therapy * Grade 1-2 Adverse event that did not return to baseline after Therapy cessation 12. Documented refractory to Obinutuzumab monotherapy 13. Active autoimmune disease requiring treatment requires investigator assessment of Immunization 14. Evidence of significant, uncontrolled concomitant disease that could affect adherence to the study protocol or interpretation of results, including Immunization, relevant Lung disorder history (Bronchospasm, Obstruction Pneumopathy), and known autoimmune Diabetes mellitus 15. History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein) 16. History of confirmed progressive multifocal Leukoencephalopathy (PML) 17. Current or past history of CNS Lymphoma 18. Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease 19. Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence) 20. Serious or extensive Angina unstable such as New York Heart disorder Association Class III or IV or objectively assessed Class C or D Cardiac disorder, Myocardial infarction within the last 6 months, unstable Arrhythmia, or Cardiovascular disorder 21. Administration of a live attenuated vaccine within 4 weeks prior to Gpt infusion, or anticipated need for a live attenuated vaccine during the study. ( Note: Flu vaccination should only be administered during the Flu season. Patients must not receive live attenuated Flu vaccine at any time during study treatment.) 22. Systemic Tumour necrosis agents (including but not limited to Cap Phosphorus amide, thiazolyl Purines, methotrexate, thalidomide, and anti Ammonia factor agents) within 2 weeks prior to Gpt infusions * Corticosteroid therapy with ≤ 25 mg/day prednisone or equivalent is allowed. * Inhaled and topical steroids are allowed. 23. History of illicit drugs or Alcohol abuse within 12 months prior to screening, as judged by the investigators. 24. Any other disease, metabolic dysfunction, Physical examination result, or clinical lab result reasonably suspecting a disease or condition that contraindicates the use of an investigational drug 25. Investigators should review the Vaccination status of potential study patients considered for this study and follow local disease control and prevention guidelines for vaccination of any other non-live vaccinated adults aiming to prevent infectious diseases prior to the study. 26. Any mental or Cognitive disorder that would limit the understanding, conduct, and compliance with the informed consent form; 27. Pregnancy or lactating females, or females or male partners planning to Pregnancy during the study; 28. Other situations that the investigators consider Discomfort to be eligible for this trial
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tianjin Medical University Cancer Insititute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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