RecruitingPhase 1NCT05794958

Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel

A Phase Ib, Open Label Study to Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel


Sponsor

Stanford University

Enrollment

20 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase Ib study to establish safety of Axi-Cel-2 in patients with Large B Cell Lymphoma (LBCL) who are at high risk of relapse.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety of giving a second dose of a CAR-T cell therapy (called axi-cel) to patients with aggressive B-cell lymphoma who relapsed after receiving their first axi-cel treatment as standard of care. **You may be eligible if...** - You have been diagnosed with a specific type of aggressive B-cell non-Hodgkin lymphoma (such as DLBCL or related types) - You received axi-cel as your second-line treatment (standard of care) and your cancer came back or did not respond - Your cancer is considered high-risk based on specific lab values (LDH above normal range) - You meet additional organ function and health criteria **You may NOT be eligible if...** - Your lymphoma is not one of the listed subtypes - You do not meet health or organ-function requirements your doctor will review 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAxicabtagene Ciloleucel

Subjects will receive a re-infusion of Axi-Cel (Axi-Cel-2) if signs and symptoms of cytokine release syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) are ≤ grade 1.


Locations(1)

Stanford University

Palo Alto, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05794958


Related Trials