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Not yet recruiting NCT06567366

CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Phase II Interventional Large B-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAR T-cell therapy, Glofitamab, Obinutuzumab.
Who it may be relevant to
Registry conditions: Large B-cell Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Center, Prospective Study Evaluating the Efficacy and Safety of CAR T-cell Therapy in Combination With Glofitamab in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Overview

The aim of this study is to evaluate the efficacy and safety of CAR T-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large B-cell lymphoma with high-risk prognostic factors.

Interventions

  • Biological CAR T-cell therapy
    Participants will receive CAR T-cell therapy via infusion on Day 0 (given as per treatment guidelines). Prior to CAR T-cell Therapy, participants will begin receiving lymphodepleting chemotherapy on Days -5 through -3 (given as per treatment guidelines).
  • Drug Glofitamab
    Glofitamab is given intravenously at a dose of 2.5mg over 4 hours on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg over 2 hours on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg over 2 hours on Day 1 of Cycles 2-6 (as relevant).
  • Drug Obinutuzumab
    Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Primary outcome measures

  • Complete Response (CR) Rate [Time frame: Up to 2 years]
Secondary outcome measures (5)
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Duration of Response (DoR) [Time frame: Up to 2 years]
  • Progression-Free Survival (PFS) [Time frame: Up to 2 years]
  • Overall Survival (OS) [Time frame: Up to 2 years]
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Signed Informed Consent Form
  • Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma (HGBL); and transformed follicular lymphoma
  • Patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-CD20 monoclonal antibody therapy
  • Patients must be willing to receive CAR-T and Glofitamab therapy and be deemed suitable for CAR-T and Glofitamab treatment by the investigator
  • Presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter > 4 cm; (3) TP53 mutation
  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy ≥12 weeks
  • Adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function

Exclusion criteria

  • Hypersensitivity to any study drug or excipient
  • History of allogeneic stem cell transplantation
  • Patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B surface antigen or core antibody); patients who test positive for HCV RNA (HCV testing only for patients who test positive for HCV antibody)
  • Presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc
  • History of HIV infection
  • Presence or concurrence of other malignancies within the past 2 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors
  • Previous anti-CD19 CAR-T therapy is not allowed
  • Pregnant or lactating women
  • Other uncontrollable medical condition that may interfere the participation of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Ruijin Hospital — Shanghai

Identifiers

NCT: NCT06567366 · Glofit-CART

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗