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

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. 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.

Conditions

Large B-cell Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Large B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Berkeley

Alta Bates Summit Medical Center, Berkeley, California, United States, 94704

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Sacramento

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States, 91817

San Diego

University of California, San Diego, San Diego, California, United States, 92037

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Denver

Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218

Newark

Medical Oncology Hematology Consultants, Newark, Delaware, United States, 19713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Allogene Therapeutics,

Allogene Study Director, STUDY_DIRECTOR, Allogene Therapeutics, Inc.

Study Record Dates

2031-08-24