Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL

NCT06570447 | Recruiting Phase 2

• 1 other identifier: GTC-RR-DLBCL01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B-Cell Lymphoma-Recurrent; Diffuse Large B-Cell Lymphoma-Refractory

Outcome Measures

Primary Outcomes (1)

• complete response rate (CR)

  To assess the complete response rate (CR) at the end of treatment with Glofitamab combination with chidamide.

  up to the end of 12 cycles of treatment (each cycle is 28 days)

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to the end of 12 cycles of treatment (each cycle is 28 days)

• Duration of Response (DoR)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• OS

  up to 2 years

Other Outcomes (1)

• To identify biomarkers

  up to 2 years

Study Arms (1)

combination therapy of Glofitamab, chidamide

EXPERIMENTAL

Each subject will be given combination therapy of Glofitamab, chidamide. Glofitamab Injection with 2.5 mg on D8 and 10 mg on D15 in Cycle 1; with 30mg in Cycle 2-12, every 3 weeks.

Drug: Glofitamab; Drug: Chidamide

Interventions

Glofitamab DRUG

For Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.

combination therapy of Glofitamab, chidamide

Chidamide DRUG

Chidamide: 30 mg/d orally twice a week for 21 days as a treatment cycle.

combination therapy of Glofitamab, chidamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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:

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

glofitamab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Central Study Contacts

Huilai Zhang

CONTACT

+86-18622221228; huilaizhangtz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma department

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 26, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)