CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight CLARITY (PhasED-seq). Participants will initially be pre-screened for MRD status after first line treatment (1L) with chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.

Eligibility criteria

Qualifiers

High grade B-cell Lymphoma (NOS, or with MYC/BCL2 rearrangements);

Double hit lymphoma (DHL) / Triple hit lymphoma (THL); OR

Follicular lymphoma grade 3b

Must have 10 unstained slides or tissue block from lymph node excision or core needle biopsy, or a lymph node biopsy (NOT FNA, bone or bone marrow biopsy), in 5 µm thickness FFPE with H&E slide available for ctDNA calibration.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Rapcabtagene autoleucel (YTB323)

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators