Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
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
Allogene Therapeutics
250 participants
Jun 18, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.
- Prior treatment with anti-CD19 targeted therapies.
- 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.
- History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Interventions
An allogeneic CAR T cell therapy targeting CD19
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
Locations(61)
View Full Details on ClinicalTrials.gov
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NCT06500273