Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!

a study on Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Sven DeVos, MD (ucla)Naseem Esteghamat, MD (ucdavis)Ayad Hamdan, MD (ucsd)Michael Spinner, MD (ucsf)
Headshot of Ayad Hamdan
Ayad Hamdan
Headshot of Michael Spinner
Michael Spinner

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.

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.

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, PMBCL, Consolidation, First-line, Front-line, Frontline, PhasED-Seq™, CLARITY™, AlloCAR T™, Lymphoma, Large B-Cell, Diffuse, Residual Neoplasm, fludarabine, fludarabine phosphate, Cyclophosphamide, Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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.
  2. 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.
  3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
  4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
  5. Adult participants ≥18 years of age.
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

You CAN'T join if...

  1. 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.
  2. Prior treatment with anti-CD19 targeted therapies.
  3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
  4. Active and clinically significant autoimmune disease.
  5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
  6. 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 Scientists at University of California Health

  • Sven DeVos, MD (ucla)
  • Naseem Esteghamat, MD (ucdavis)
    Assistant Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 10 research publications
  • Ayad Hamdan, MD (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 14 research publications
  • Michael Spinner, MD (ucsf)
    I am a hematologist/oncologist and care for patients with blood cancers with a particular focus on Hodgkin lymphoma, non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and Waldenstrom macroglobulinemia. I have a particular interest in immunotherapy, targeted therapies, stem cell transplantation, and CAR T-cell therapy.

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
Contact us about this trial