Clinical Trial 23198

• Overview

  Study Title:

  CCT5065: Optimizing ctDNA-based MRD assessment in DLBCL, MCL, and FL patients undergoing CAR Therapy

  Objective:

  For each of DLBCL, FL, and MCL patients undergoing therapy with commercially available anti-CD19 CAR-T products, the primary aim of this study is to prospectively assess the clonoSEQ-based minimal residual disease (MRD) assessment s ability to predict progression free survival following CAR infusion. MRD will be assessed at 28 days post CAR infusion, using both ctDNA and CTCs. For all patients, this assessment will begin with six months PFS analysis and extend with planned analyses for 12 and 18 months following CAR infusion. Secondary Objectives A. Prospectively determine the correlation between circulating tumor DNA (ctDNA) based MRD assessment in DLBCL/FL/MCL patients treated with commercial anti-CD19 CAR-T therapy and tumor burden assessed by Metabolic Tumor Volume (MTV). B. Perform exploratory analyses of the clinical utility of MRD assessment in predicting the progression free survival of DLBCL/FL/MCL patients. This includes, but is not limited to, multiple MRD timepoints, alternative MRD thresholds, and trajectories of MRD growth. C. Determine the correlation between ctDNA and CTC based MRD assessments in DLBCL/FL/MCL patient treated with commercial anti-CD19 CAR-T therapy.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Immunophenotypically confirmed diagnosis of follicular lymphoma (FL), Immunophenotypically confirmed diagnosis of Large B Cell Lymphoma (LBCL) (including transformed FL and Primary Mediastinal B-cell Lymphoma) OR Immunophenotypically confirmed diagnosis of mantle cell lymphoma (MCL) undergoing commercially approved CAR-T therapy in accordance with FDA indication with enrollment in this trial prior to CAR infusion
  • CAR-T product must meet manufacturer specifications
  • PET measurable disease at the time a decision is made to prescribe CAR treatment
  • Has sample from diagnosis or relapse available for genomic DNA extraction to identify patient's clonotype via clonoSEQ (see lab manual for details)

• Exclusion Criteria

  Key Exclusion Criteria:
  • Lack of archival diagnostic or fresh/archival relapse tissue for purposes of determining patient's lymphoma clonotype. Given that 5-10% of patients cannot have a clonotype identified by clonoSEQ, those patients will be removed from the study and excluded from analysis, but their samples will continued to be stored for future analysis as improvements to the analysis platform are made.
  • No patients are to be excluded on the basis of gender, race, ethnic background, sexual orientation, or other demographic characteristics.

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