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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
cemacabtagene ansegedleucel, ALLO-647 		Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine, cyclophosphamide, and ALLO-647.
  • Genetic: cemacabtagene ansegedleucel
    An allogeneic CAR T cell therapy targeting CD19
    Other names:
    • cema-cel
  • Biological: ALLO-647
    A monoclonal antibody targeting CD52
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
    Other names:
    • Fludara®
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
    Other names:
    • Cytoxan®
  • Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
    A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for lLBCL.
    Other names:
    • Foresight Lymphoma MRD Therapy Selection Test
Experimental
cemacabtagene ansegedleucel 		Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
  • Genetic: cemacabtagene ansegedleucel
    An allogeneic CAR T cell therapy targeting CD19
    Other names:
    • cema-cel
  • Biological: ALLO-647
    A monoclonal antibody targeting CD52
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
    Other names:
    • Fludara®
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
    Other names:
    • Cytoxan®
  • Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
    A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for lLBCL.
    Other names:
    • Foresight Lymphoma MRD Therapy Selection Test
Other
Observation 		Participants do not receive any study treatments. They are observed as per the current standard of care.
  • Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
    A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for lLBCL.
    Other names:
    • Foresight Lymphoma MRD Therapy Selection Test

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Allogene Therapeutics

Study Contact

Allogene Therapeutics, Inc
+1 415-604-5696
clinicaltrials@allogene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.