NCT06213311

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives * To evaluate the safety of axicabtagene ciloleucel (axi-cel) and glofitamab as combination therapy in 2nd line LBCL participants * To evaluate the effect of axi-cel and glofitamab as combination therapy on the best complete response rate in 2nd line LBCL participants Secondary Objectives * To evaluate the effect of axi-cel and glofitamab as combination therapy on overall survival (OS) in 2nd line LBCL participants * To evaluate the effect of axi-cel and glofitamab as combination therapy on progression free survival in 2nd line LBCL participants * To evaluate the effect of axi-cel and glofitamab as combination therapy on best overall response rate in 2nd line LBCL participants Exploratory Objectives * Characterization of tumors via tumor profiling and antigen density measurement using flow cytometry at baseline * Characterization of genetic markers via tumor single cell (sc) multiome sequencing and whole exome sequencing (WES) at baseline * To study the kinetics of circulating tumor DNA (ctDNA) during study progression * To evaluate the development of anti-axi-cel antibodies during study progression * To evaluate the effect of glofitamab administration on T cell exhaustion during study progression

Conditions

• B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Glofitamab	Given by IV
DRUG	Obinutuzumab	Given by IV
DRUG	Axi-cel	Given by IV

Timeline

• Start date: 2024-05-07
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2024-01-19
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study