Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

About

Brief Summary

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Age 18 years or older
Willing and able to provide written informed consent
Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
Relapsed or refractory disease.
At least 1 measurable lesion (per Lugano classification)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
Absolute neutrophil count (ANC) ≥ 1000/µL
Platelet count ≥ 50,000/µL
Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply.

Exclusion Criteria:

History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
Active central nervous system involvement
History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
Ongoing or impending oncologic emergency
Recent systemic anti-cancer therapy or radiation
Ongoing non-hematologic toxicities due to prior therapy
History of allogeneic stem cell or solid organ transplantation
Autologous stem cell transplantation within 6 weeks
History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
Primary immunodeficiency
History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.