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Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma

ConditionsRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLyell Immunopharma, Inc.

About this trial

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Willing and able to provide written informed consent

Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)

Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3

Disqualifiers

History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years

Active central nervous system involvement

History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma

Ongoing or impending oncologic emergency

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rondecabtagene autoleucel (ronde-cel)

    Drug

    CAR T-cell therapy

  • Fludarabine

    Drug

    Conditioning chemotherapy

  • Cyclophosphamide

    Drug

    Conditioning chemotherapy

Treatment groups

270 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Ph1, 3rd or later line, 3L+ have not received prior CAR T (Cohort 1)Experimental treatment 3 interventions
Group B: Ph1 CAR T experienced, 3L+ received at least two or more prior lines of treatment (Cohort 2)Experimental treatment 3 interventions
Group C: Ph1, 2L Refractory/relapse within 1 year of 1st-line therapy & no prior CAR T (Cohort 3)Experimental treatment 3 interventions
Group D: Ph1 (T-cell engager experienced, 3L+) received at least 2 prior lines including 1 TCE (Cohort 4)Experimental treatment 3 interventions
Group E: Ph1 high risk 1st line, PET-positive after 2-3 cycles chemoimmunotherapy, no prior CAR T (Cohort 5)Experimental treatment 3 interventions
Group F: Ph2, 3rd or later line, have not received prior CAR T (Cohort 1)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent

Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs)

Time frame
Baseline to Month 24
2

Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR)

ORR based on Independent Review Committee (IRC) assessment per Lugano criteria

Time frame
Baseline to Month 24

Secondary outcomes

1

Phase 1: Evaluate the efficacy of ronde-cel

Overall response rate (ORR), Complete response rate (CRR), duration of response (DOR), duration of complete response (DOCR), progression free survival (PFS) based on Investigator assessment until a pivotal trial (Phase 2) portion is initiated at which time all scans will be reviewed by an IRC assessment (Cohort 1) per Lugano criteria

Time frame
Baseline to Month 24
2

Phase 1: Evaluate the feasibility of treatment with ronde-cel

Proportion of enrolled participants who receive the target dose of ronde-cel

Time frame
Baseline to Month 24
3

Phase 1: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent

Maximum concentration (Cmax), area under the curve from time 0 to Day 28 (AUC0-28) and persistence of ronde-cel

Time frame
Baseline to Month 24
4

Phase 2: Estimate the efficacy of ronde-cel

ORR based on Investigator assessment per Lugano criteria

Time frame
Baseline to Month 24

Other outcomes

Sponsors and contacts

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

Lyell Immunopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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