A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.

• Fludarabine (Conditional therapy) (Drug): Lymphodepletion chemotherapy
• Cyclophosphamide Monohydrate (Conditional therapy) (Drug): Lymphodepletion chemotherapy
• firi-cel (Experimental drug) (Drug): Investigational agent

Primary outcomes

• Objective response rate - Blinded independent review [Up to 24 months]: Percentage of patients with complete or partial response determined by a blinded independent review committee

Secondary outcomes

• Objective response rate - Investigator assessment [Up to 24-months]: Percentage of patients with complete or partial response determined by the investigator
• Complete response rate [Up to 24-months]: Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment
• Duration of response [Up to 24-months]: Duration of response (the time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators
• Duration of complete response [Up to 24-months]: Time from the date of the first occurrence of CR to the date of progression, relapse, or death from any cause determined by independent review committee and investigators.
• Progression-free survival [Up to 24-months]: Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment
• Overall Survival [Up to 24-months]: Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.
• Incidence rate of adverse events [From Screening up to 15 years at protocol-defined timepoints]: Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* Aged ≥18 years
* Relapsed or refractory, histologically confirmed large B-cell lymphoma.
* Must have relapsed or refractory diseae after last therapy.
* For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
* For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.
* Must have at least one radiographically measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological, renal, and liver function
* Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.

Key Exclusion Criteria:

* Clinically significant concurrent medical illness
* Active fungal, bacterial, viral or other infection.
* Prior allogeneic stem cell transplant or allogeneic cell therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.