Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Key facts
- Where
- Goyang-si, Hwasun, Seogu, Seoul, and Suwon, South KoreaSee the 9 sites
- Phase
- Phase 2
Where in South Korea
- National Cancer CenterGoyang-si, South KoreaTaking people
- Chonnam National University Hwasun HospitalHwasun, South KoreaTaking people
- Pusan National University HospitalSeogu, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National UniversitySeoul, South KoreaTaking people
- Severance Hospital, Yonsei University Health SystemSeoul, South KoreaTaking people
- The Catholic University of Korea Yeouido St. Mary's HospitalSeoul, South KoreaTaking people
- Ajou University HospitalSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Allogene Therapeutics
- Trial code
- NCT06500273
- Record updated
- 30 October 2026
- Original description
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.Read full original descriptionShow less
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.
Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
Inclusion: LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report; Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy; Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation; Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive; Adult participants ≥18 years of age; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; Adequate hematological, renal, hepatic, pulmonary, and cardiac function; Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.
Exclusion: Prior treatment with anti-CD19 targeted therapies; History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment; LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL; Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed; Active and clinically significant autoimmune disease; Active systemic bacterial, fungal, or viral infections requiring systemic treatment.