Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
a study on Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UCLA UCSD UCSF
- Dates
- study startedcompletion around
- Principal Investigator
- by Sven de Vos, MD, PhD (ucla)

Description
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.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.
Official Title
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
Keywords
Large B-cell Lymphoma, Diffuse large B-cell lymphoma, DLBCL, Primary mediastinal B-cell lymphoma, LBCL, High grade B-cell lymphoma, HGBCL, Double-hit lymphoma, High-risk lymphoma, Minimal Residual Disease, MRD, CAR T, Allogeneic CAR T, CD19, cema-cel, cemacabtagene ansegedleucel, ALLO-647, PMBCL, Consolidation, First-line, Front-line, Frontline, PhasED-Seq™, CLARITY™, Anti-CD52, AlloCAR T™, Lymphoma, B-Cell Lymphoma, Cyclophosphamide, Fludarabine, Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, cemacabtagene ansegedleucel, ALLO-647
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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 (e.g., HIV).
- History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Locations
- University of California, Los Angeles
accepting new patients
Los Angeles California 90095 United States - University of California, Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 91817 United States - University of California, San Diego
accepting new patients
San Diego California 92037 United States - University of California, San Francisco
accepting new patients
San Francisco California 94143 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States - Alta Bates Summit Medical Center
accepting new patients
Berkeley California 94704 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Lead Scientist at University of California Health
- Sven de Vos, MD, PhD (ucla)
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Allogene Therapeutics
- ID
- NCT06500273
- Phase
- Phase 2 Lymphoma Research Study
- Study Type
- Interventional
- Participants
- Expecting 250 study participants
- Last Updated