Open Actively Recruiting

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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

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Study Stats
Protocol No.
24-5791
Category
Lymphoma
Contact
Marvin Valencia
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06500273
For detailed technical eligibility, visit ClinicalTrials.gov.