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

ConditionLarge-cell Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Rapcabtagene autoleucel (YTB323)

    Biological/Vaccine

    Autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy manufactured from participant-derived T cells. Participants undergo leukapheresis for cell collection, receive lymphodepleting chemotherapy, followed by a single intravenous infusion of rapcabtagene autoleucel (YTB323).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Observational Cohort (MRD-Negative)No intervention 0 interventions
Group B: Rapcabtagene Autoleucel (YTB323) Treatment CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Minimal Residual Disease (MRD) Conversion Rate at Day 90

Proportion of participants who achieve conversion from MRD-positive status at baseline to MRD-negative status at Day 90 (± 2 weeks) following infusion of rapcabtagene autoleucel (YTB323).

Time frame
Day 90 (3 months ± 2 weeks) post-infusion

Secondary outcomes

1

Progression free survival

Progression free survival (PFS) at 12 months from study treatment infusion as compared to historic controls (approximately 18 months from start of frontline therapy).

Time frame
12 months
2

Incidence of Adverse Events

Number of participants experiencing treatment-emergent adverse events following infusion of rapcabtagene autoleucel (YTB323), graded according to CTCAE criteria.

Time frame
From infusion through Day 28 post-infusion
3

Incidence of Dose-Limiting Toxicities (DLTs)

Number of participants experiencing dose-limiting toxicities (DLTs) following infusion of rapcabtagene autoleucel (YTB323), as defined per protocol.

Time frame
From infusion through Day 28 post-infusion

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Novartis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: