Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Naseem Esteghamat, MD (ucdavis)

Description

Summary

This is a randomized, open-label study in adult patients who have completed standard first line of 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

  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 (e.g., HIV).
  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, Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 91817 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

  • Naseem Esteghamat, MD (ucdavis)
    Assistant Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 8 research publications

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