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Studie för att utvärdera effekten av Brexucabtagene Autoleucel (KTE-X19) hos deltagare med återfall/refraktärt mantelcellslymfom (kohort 3) (ZUMA-2)

24 juli 2026 uppdaterad av: Kite, A Gilead Company

En fas 2 multicenterstudie som utvärderar effektiviteten av KTE-X19 hos patienter med återfall/refraktärt mantelcellslymfom

Det primära målet är att utvärdera effekten av brexucabtagene autoleucel (KTE-X19) hos deltagare med återfall/refraktär (r/r) mantelcellslymfom (MCL) i kohort 3 av denna studie.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studie KTE-C19-102 (NCT02601313) inkluderade deltagare med r/r MCL som har behandlats med upp till 5 tidigare regimer inklusive en Brutons tyrosinkinashämmare (BTKi) i kohort 1 och kohort 2. Men för att uppfylla FDA:s eftermarknadsföringskrav Cohort 3 läggs till studien. Det kommer att inkludera deltagare med r/r MCL som har behandlats med upp till 5 tidigare regimer men som inte har fått tidigare terapi med en BTKi.

Den primära analysen i Kohort 1 och Cohort 2 är redan klar. Data för kohort 3 kommer att analyseras separat. Därför är denna separata registrering endast för Cohort 3.

Efter slutet av KTE-C19-102 kommer försökspersoner som fått en infusion av anti-CD19 CAR T-celler att slutföra resten av de 15-åriga uppföljningsbedömningarna i en separat långtidsuppföljningsstudie, KT-US- 982-5968

Studietyp

Interventionell

Inskrivning (Faktisk)

95

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34295
        • CHU de Montpellier
      • Paris, Frankrike, 75010
        • Hospital Saint Louis
      • Pessac, Frankrike, 44035
        • Hôpital Haut-Lévêque
      • Pierre-Bénite, Frankrike, 69495
        • Centre Hospitalier LYON SUD
      • Rennes, Frankrike, 35033
        • CHU de Rennes
  • Förenta staterna
    • Arizona
      • Gilbert, Arizona, Förenta staterna, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Palo Alto, California, Förenta staterna, 94305
        • Stanford University
      • Santa Monica, California, Förenta staterna, 90404
        • University California Los Angeles (UCLA)
    • Colorado
      • Denver, Colorado, Förenta staterna, 80218
        • Sarah Cannon- Denver
    • Florida
      • Miami, Florida, Förenta staterna, 33136
        • University of Miami
      • Tampa, Florida, Förenta staterna, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago
      • Maywood, Illinois, Förenta staterna, 60153
        • Loyola University Medical Center
      • Park Ridge, Illinois, Förenta staterna, 60068
        • Advocate Aurora Health - Advocate Lutheran General Hospital
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48201
        • Karmanos Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Hackensack University Medical Center
    • New York
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic - Taussig Cancer Institute
      • Columbus, Ohio, Förenta staterna, 43220
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University
      • Nashville, Tennessee, Förenta staterna, 37203
        • Sarah Cannon - Tenessee
    • Texas
      • Dallas, Texas, Förenta staterna, 75246
        • Baylor Cancer Hospital
      • Houston, Texas, Förenta staterna, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Swedish Cancer Institute
  • Nederländerna
      • Amsterdam, Nederländerna, 1100
        • Academisch Medisch Centrum
      • Groningen, Nederländerna, 9700 RB
        • University Medical Center Groningen
      • Rotterdam, Nederländerna, 3015 CE
        • Erasmus MC
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spanien
        • Hospital Clinic Barcelona
      • Salamanca, Spanien, 37007
        • Hospital Universitario De Salamanca
  • Storbritannien
      • Glasgow, Storbritannien, G51 4TF
        • Queen Elizabeth University Hospital
      • London, Storbritannien, SE5 9RS
        • Kings College Hospital
      • Manchester, Storbritannien, M13 9WL
        • Manchester Royal Infirmary
  • Tyskland
      • Mainz, Tyskland, 55101
        • Johannes Gutenberg University Hospital-University Mainz
      • München, Tyskland, 81377
        • Munich University of Technology-Medical Faculty- Ethics Committee
      • Würzburg, Tyskland, 97080
        • Universitaetsklinikum Wuerzburg

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Viktiga inkluderingskriterier:

  • Upp till 5 tidigare regimer för MCL. Tidigare behandling måste ha inkluderat antracyklin- eller bendamustin-innehållande kemoterapi och anti-CD20 monoklonal antikroppsbehandling. Individer får inte ha fått tidigare terapi med en BTKi.
  • Minst 1 mätbar lesion
  • Trombocytantal ≥ 75 000/uL
  • Kreatininclearance (uppskattat av Cockcroft Gault) ≥ till 60 cc/min
  • Hjärtutdrivningsfraktion ≥ 50 %, inga tecken på perikardiell utgjutning, fastställd med ett ekokardiogram (ECHO) eller multigated acquisition (MUGA), och inga kliniskt signifikanta elektrokardiogram (EKG) fynd
  • Baslinje syremättnad > 92 % på rumsluft

Viktiga uteslutningskriterier:

  • Känd historia av infektion med humant immunbristvirus (HIV) eller hepatit B (HBsAG-positiv) eller hepatit C-virus (anti-HCV-positiv). Individer med en historia av hepatitinfektion måste ha klarat sin infektion enligt standard serologiska och genetiska tester
  • Historik med krampanfall, cerebrovaskulär ischemi/blödning, demens, cerebellär sjukdom, cerebralt ödem, posteriort reversibelt encefalopatisyndrom eller någon autoimmun sjukdom med inblandning i centrala nervsystemet (CNS)
  • Förekomst av svamp-, bakterie-, virus- eller annan infektion som är okontrollerad eller som kräver IV-antimikrobiella medel för behandling

Obs: Andra protokolldefinierade kriterier för inkludering/uteslutning kan gälla.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Brexucabtagene autoleucel (KTE-X19)

Participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have been treated with up to 5 prior regimens but have not received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi) will receive the following treatment during the study:

  • A conditioning chemotherapy regimen of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day for 3 days (Day -5 to Day -3).
  • A single infusion of brexucabtagene autoleucel at a target dose of 2×10^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg, with a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells for participants > 100 kg on Day 0.
Läkemedel: Fludarabine
Administered as intravenous infusion
Läkemedel: Cyclophosphamide
Administered as intravenous infusion
Biologisk: Brexucabtagene autoleucel
Administered as intravenous infusion
Andra namn:
  • Tecartus™
  • KTE-X19

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 3
Tidsram: Up to 4 years
OR: complete metabolic response (CMR),complete radiological response (CRR), partial MR response (PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤mediastinum)/3(uptake >mediastinum but ≤liver) with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤1.5cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately >liver)/5(uptake markedly >liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT). PRR: ≥50% decrease in sum of the product of the diameters(SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by >50% in length beyond normal.
Up to 4 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Andel deltagare med anti-CD19 CAR-antikroppar
Tidsram: Baslinje upp till månad 3
Baslinje upp till månad 3
Toppserumnivåer av C-reaktivt protein (CRP) i blod
Tidsram: Baslinje fram till vecka 4
Toppen definierades som den maximala post-baslinjenivån av cytokinet.
Baslinje fram till vecka 4
Duration of Response (DOR) Per the Lugano Classification According to IRRC in Cohort 3
Tidsram: Up to 4 years
DOR: time from the first OR to progressive disease (PD)/death. It was determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately > liver)/ 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
Up to 4 years
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
Tidsram: Up to 4 years
BOR consisted of complete response (CR), partial response (PR), stable disease (SD), PD, not done and not evaluable (NE). CR=CMR/CRR and PR=PMR/PRR were defined in Outcome Measure (OM) 1. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than (>) liver) or 5 (uptake markedly >liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. PD was defined in OM 2. Not done: no assessment at the time of analysis. Clopper-Pearson method was used for OM analysis. Percentages were rounded off.
Up to 4 years
Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 3
Tidsram: Up to 4 years
OR was defined in OM #1. Percentages were rounded-off.
Up to 4 years
Progression Free Survival (PFS) Per the Lugano Classification According to IRRC in Cohort 3
Tidsram: Up to 4 years
PFS was defined as the time from brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD was defined in OM #2. Kaplan-Meier (KM) estimates were used for analysis.
Up to 4 years
Overall Survival (OS)
Tidsram: Up to 4 years
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. KM estimates were used for analysis.
Up to 4 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Tidsram: Up to 3 years
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participants. The event did not necessarily have a relationship with study treatment. AE included worsening of a pre-existing medical condition. Worsening indicated that the pre-existing medical condition had increased in severity, frequency, and/or duration or had an association with a worse outcome. A pre-existing condition that had not worsened during the study or involved an intervention such as elective cosmetic surgery or a medical procedure while on study, was not considered an AE. TEAE was defined as any AE with onset on or after the start of treatment.
Up to 3 years
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Tidsram: Up to 3 years
Laboratory results were graded according to National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE) version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Tidsram: Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Tidsram: Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Tidsram: Up to 3 years
Laboratory results were graded according to National Cancer Institute CTCAE version 4.03. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 life-threatening. Percentages were rounded-off.
Up to 3 years
Maximum Number of CAR T Cells Measured Post-infusion
Tidsram: Up to Month 36
Up to Month 36
Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-gamma (IFN-γ), Interleukin (IL)-1 Receptor Antagonist (RA), IL-2, IL-6, IL-7, IL-8, IL-10, IL-15 and Tumor Necrosis Factor (TNF)-α in Blood
Tidsram: Baseline up to Week 4
Peak was defined as the maximum post-baseline level of the cytokine.
Baseline up to Week 4
Peak Serum Levels of Ferritin, Intercellular Adhesion Molecule (ICAM)-1, IL-2 Receptor Alpha (Rα), Perforin and Vascular Cell Adhesion Molecule (VCAM)-1 in Blood
Tidsram: Baseline up to Week 4
Peak was defined as the maximum post-baseline level of the cytokine.
Baseline up to Week 4
Percentage of Participants With European Quality of Life-5 Dimensions (EQ-5D) Scale Score at Different Timepoints
Tidsram: Day 0, Month 18 and Month 24
The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) was a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant was asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, were converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. Percentage of participants with each scale score for all 5 dimensions are reported. Percentages were rounded-off.
Day 0, Month 18 and Month 24
EQ-5D Visual Analogue Scale (VAS) Score at Different Timepoints
Tidsram: Day 0, Month 18 and Month 24
EQ-5D was a standardized participant completed questionnaire that measures health-related quality of life and translated the score into an index value or utility score. EQ-5D-consisted of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5D-VAS recorded the participant's self-rated health on a vertical visual analogue scale, where the endpoints were labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicated better self-reported health status.
Day 0, Month 18 and Month 24
Percentage of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Tidsram: Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24
EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status/quality of life (QoL) scale, symptom scales (fatigue, pain, nausea/vomiting), and single items scales (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged, transformed to 0-100 scale. Higher scores for functional scales and for the global health status/QoL scale indicate a higher level of functioning and a better health-related QoL, whereas higher scores in symptom scales represent a higher level of symptoms. Deterioration of score was defined as worsened by at least 1 level from screening. Participants with answer "Yes" to the EORTC functional scale questionnaire were reported.
Screening Day -28 to Leukapheresis (Day -5), Day 0, Month 18 and Month 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kite, A Gilead Company

Utredare

  • Studierektor: Kite Study Director, Kite, A Gilead Company

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 april 2021

Primärt slutförande (Faktisk)

17 juni 2025

Avslutad studie (Faktisk)

17 juni 2025

Studieregistreringsdatum

Först inskickad

30 april 2021

Först inskickad som uppfyllde QC-kriterierna

5 maj 2021

Första postat (Faktisk)

10 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KTE-C19-102 (Cohort 3)
  • 2015-005008-27 (EudraCT-nummer)
  • 2023-506641-35 (Annan identifierare: European Medicines Agency)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

Tidsram för IPD-delning

18 months after study completion and at least 6 months after the FDA and EMA approval

Kriterier för IPD Sharing Access

A secured external environment with username, password, and RSA code.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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