Study on Using Cema-cel for Patients with Large B-Cell Lymphoma in Minimal Residual Disease Remission

Sponsor: Allogene Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06500273

Provider View

This clinical trial is testing a new treatment called cema-cel for patients with large B-cell lymphoma (LBCL) who have responded to initial therapy but still have minimal residual disease (MRD). The study aims to see if cema-cel can help improve outcomes compared to just monitoring the disease.

Patient Parameters

Program Overview

This study is for adults with large B-cell lymphoma (LBCL) who have completed their first round of standard treatment and have shown a complete or partial response, but still have minimal residual disease (MRD) detected by a special test. The trial will compare the effectiveness and safety of a new treatment called cema-cel, a type of CAR T-cell therapy, against the standard approach of observing the disease without additional treatment. The study is divided into two parts: Part A will test different treatment regimens to find the best one, and Part B will compare the selected regimen with standard observation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with large B-cell lymphoma, including specific subtypes confirmed by a pathology report.
  • Completed a full course of standard first-line therapy for LBCL.
  • Achieved a complete or partial response suitable for observation after initial therapy, as shown by PET/CT scans.
  • Tested positive for minimal residual disease (MRD) using the Foresight CLARITY™ test.
  • Adults aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood, kidney, liver, lung, and heart function.
  • Any side effects from previous treatments must have improved to baseline levels or be mild.

Exclusion Criteria

  • History of LBCL affecting the central nervous system or transformed from another type of cancer.
  • Previous treatment with therapies targeting CD19.
  • Received any cancer treatment, including radiation, after the end of initial therapy and MRD testing.
  • Have an active and significant autoimmune disease.
  • Have active infections requiring treatment, such as HIV.
  • Have had another primary cancer or bone marrow disorder within the last 3 years.

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