Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

Recruiting now · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma-Recurrent, Diffuse Large B-Cell Lymphoma-Refractory

In brief

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Key facts

Study ID

NCT06570447

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

22

Starts

2025-02-27

Expected to finish

2028-12-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for enrollment in this study, a subject must meet all of the following criteria:
• Signed informed consent
• Age ≥ 18 years at the time of informed consent
• 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.
• 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).
• 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.
• 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.
• 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.
• Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1
• Life expectancy (as assessed by the investigator) ≥ 12 weeks
• Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).
• 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
• 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
• 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)
• 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.
• For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception

You may not qualify if…

• Any subject who meets any of the following criteria should not be enrolled in the study:
• Inability to comply with protocol-specified hospitalization and restrictions
• Richter's transformation
• 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
• Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
• 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.
• 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.
• Known HIV seropositive status
• For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.
• Known or suspected chronic active Epstein-Barr Viral infection
• Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH)
• 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
• 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
• Documented refractory to Obinutuzumab monotherapy
• Active autoimmune disease requiring treatment requires investigator assessment of Immunization
• 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
• History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein)
• History of confirmed progressive multifocal Leukoencephalopathy (PML)
• Current or past history of CNS Lymphoma
• Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease
• Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence)

Where it is running

• Tianjin Medical University Cancer Insititute & Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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