Not Yet RecruitingPhase 1

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

20 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022\[1\]:
✓. 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.
✓. Must have intention to complete frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.
✓. In the investigator's assessment, is likely to be eligible to proceed to the treatment portion of this study with intention to undergo YTB323 if MRD positive.
✓. Must be able to understand and the willingness to sign the written IRB approved pre-screening informed consent document.

What they're measuring

Minimal Residual Disease (MRD) Conversion Rate at Day 90

Timeframe: Day 90 (3 months ± 2 weeks) post-infusion

Trial details

NCT IDNCT07443137

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Sunny Salazar

(650) 725-7540 sunnysw@stanford.edu

View on ClinicalTrials.gov More Large-cell Lymphoma trials