RecruitingPhase 2NCT06213311

A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To learn if the combination of axicabtagene ciloleucel (axi-cel) and glofitamab as first-line therapy in high-risk LBCL participants or as second-line therapy in LBCL participants can help to control the disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two advanced cancer treatments — axicabtagene ciloleucel (a CAR T-cell therapy that reprograms your immune cells to fight cancer) and glofitamab (a bispecific antibody that helps immune cells attack cancer) — as a second-line treatment for large B-cell lymphoma (an aggressive blood cancer) that has come back or stopped responding within 12 months of initial treatment. **You may be eligible if...** - You are 18 or older - You have large B-cell lymphoma confirmed by biopsy - Your cancer came back or stopped responding within 12 months of completing your first chemotherapy - You received a standard first-line treatment that included an anti-CD20 drug and an anthracycline-based chemotherapy - Your blood counts and organ function are within acceptable ranges - You are in reasonably good physical health **You may NOT be eligible if...** - Your cancer did not respond to first-line therapy but you could not tolerate the treatment - You have active untreated infection or serious medical conditions affecting your heart, kidneys, or liver - You have another active cancer - You have a history of certain brain conditions or significant neurological problems - You cannot comply with the required hospitalization after the first dose Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlofitamab

Given by IV

DRUGObinutuzumab

Given by IV

DRUGAxi-cel

Given by IV


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06213311


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