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JOURNAL ONKOLOGIE – STUDIE

A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases

Rekrutierend

NCT-Nummer:
NCT04554914

Studienbeginn:
Juli 2021

Letztes Update:
24.10.2023

Wirkstoff:
tabelecleucel

Indikation (Clinical Trials):
Epstein-Barr Virus Infections, Leiomyosarcoma, Lymphoproliferative Disorders, Primary Immunodeficiency Diseases, Immunologic Deficiency Syndromes

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Atara Biotherapeutics

Collaborator:
-

Studienleiter

Justin Wahlstrom, MD
Study Director
Atara Biotherapeutics

Kontakt

Study Director
Kontakt:
Phone: 650-278-8930
Phone (ext.): option 1
E-Mail: clinicalstudies@atarabio.com» Kontaktdaten anzeigen

Studienlocations
(3 von 40)

University of California Los Angeles (UCLA) (Adults and Pediatrics)
90095 Los Angeles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Herbert Eradat, MD
Phone: 310-794-6376
E-Mail: heredat@mednet.ucla.edu» Ansprechpartner anzeigen
Children's Hospital of Orange County (Pediatrics [up to 25 years old])
92868 Orange
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Lilibeth Torno, MD
Phone: 714-509-4348
E-Mail: ltorno@choc.org» Ansprechpartner anzeigen
Lucile Packard Children's Hospital Stanford (Pediatrics only)
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Lianna Marks, MD
Phone: 650-497-8953
E-Mail: marksl@stanford.edu» Ansprechpartner anzeigen
University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)
95817 Sacramento
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Mehrdad Abedi, MD
Phone: 916-734-3772
E-Mail: mabedi@ucdavis.edu» Ansprechpartner anzeigen
Sylvester Comprehensive Cancer Center/ University of Miami
33136 Miami
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Warren Alperstein, MD
Phone: 305-243-7925
E-Mail: walperstein@miami.edu» Ansprechpartner anzeigen
Moffit Cancer Center (Adults only)
33612 Tampa
United StatesZurückgezogen» Google-Maps
Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Shanmuganathan Chandrakasan, MD
Phone: 404-727-8877
E-Mail: shanmuganathan.chandrakasan@choa.org» Ansprechpartner anzeigen
Emory University/Winship Cancer Institute (Adults [>= 16 years])
30322 Atlanta
United StatesZurückgezogen» Google-Maps
Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)
60611 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Sonali Chaudhury, MD
Phone: 312-227-4090
E-Mail: schaudhury@luriechildrens.org» Ansprechpartner anzeigen
Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)
02215 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Sarah Nikiforow, MD
Phone: 617-632-3477
E-Mail: sarah_nikiforow@dfci.harvard.edu» Ansprechpartner anzeigen
University of Michigan Rogel Cancer Center (Adults and Pediatrics)
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Monalisa Ghosh, MD
Phone: 734-232-4484
E-Mail: ghoshm@med.umich.edu» Ansprechpartner anzeigen
Washington University in St. Louis (Adults only)
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Armin Ghobadi, MD
Phone: 314-747-2743
E-Mail: arminghobadi@wustl.edu» Ansprechpartner anzeigen
The Children's Hospital at Montefiore (Adults and Pediatrics)
10467 Bronx
United StatesRekrutierend» Google-Maps
Ansprechpartner:
David Loeb, MD
Phone: 718-920-4664
E-Mail: david.loeb@einsteinmed.org» Ansprechpartner anzeigen
Columbia University Irving Medical Center (Adults only)
10032 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)
10065 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kevin Curran, MD
Phone: 212-639-5836
E-Mail: currank@mskcc.org» Ansprechpartner anzeigen
Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)
44195 Cleveland
United StatesZurückgezogen» Google-Maps
The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Robert Baiocchi, MD
Phone: 614-915-2084
E-Mail: robert.baiocchi@osumc.edu» Ansprechpartner anzeigen
Oregon Health and Science University (Adults and Pediatrics)
97239 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Eneida Nemecek, MD
Phone: 503-494-5058
E-Mail: nemeceke@ohsu.edu» Ansprechpartner anzeigen
Medical University of South Carolina (Adults and Pediatrics)
29425 Charleston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Michelle Hudspeth, MD
Phone: 843-792-0381
E-Mail: hudspeth@musc.edu» Ansprechpartner anzeigen
University of Texas Southwestern Medical Center (Pediatrics only)
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Victor Aquino, MD
Phone: 214-648-8800
E-Mail: victor.aquino@utsouthwestern.edu» Ansprechpartner anzeigen
Medizinische Universität Graz (Adults only)
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Hildegard Greinix, MD
Phone: 43 3 163 858 4086
E-Mail: hildegard.greinix@medunigraz.at» Ansprechpartner anzeigen
Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)
1020 Bruxelles
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Christine Devalk, MD
Phone: 32 24773113
E-Mail: christine.devalck@huderf.be» Ansprechpartner anzeigen
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)
8000 Brugge
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Sylvia Snauwaert, MD
Phone: 32 50-45-21-11
E-Mail: sylvia.snauwaert@azsintjan.be» Ansprechpartner anzeigen
Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)
8800 Roeselare
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Dries Deeran, MD
Phone: 32 51 23 76 56
E-Mail: dries.deeren@azdelta.be» Ansprechpartner anzeigen
Hôpital Saint-Eloi (Adults and Pediatrics)
34295 Montpellier Cedex 5
FranceRekrutierend» Google-Maps
Ansprechpartner:
Charles Herbaux, MD
Phone: 33 4 67 33 67 33
E-Mail: c-herbaux@chu-montpellier.fr» Ansprechpartner anzeigen
Hôpital Universitaire Pitié Salpêtrière (Adults only)
75013 Paris
FranceRekrutierend» Google-Maps
Ansprechpartner:
Sylvain S Choquet, MD
Phone: 33 1 42 16 28 26
E-Mail: sylvain.choquet@aphp.fr» Ansprechpartner anzeigen
Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)
00165 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Franco Locatelli, MD
Phone: 39 06 68592129
E-Mail: franco.locatelli@opbg.net» Ansprechpartner anzeigen
Hospital Universitario Ramón y Cajal (Adults only)
28034 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Javier López Jiménez, MD
Phone: 34 91-336-80-00
E-Mail: jlopezj.hrc@salud.madrid.org» Ansprechpartner anzeigen
Hospital Universitario Viegen del Rocio (Adults and Pediatrics)
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
Jose Antonio Perez Simon, MD
Phone: 34 9 55 01 31 61
E-Mail: josea.perez.simon.sspa@juntadeandalucia.es» Ansprechpartner anzeigen
University Hospital Birmingham NHS Foundation Trust (Adults only)
B15 2TH Birmingham
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Sridhar Chiganti, MD
Phone: 44 012 1 371 4379
E-Mail: sridhar.chaganti@uhb.nhs.uk» Ansprechpartner anzeigen
Great Ormond Street Hospital (Pediatrics only)
WC1N 3JH London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Persis Amrolia, MD
Phone: 44 020 7813 8434
E-Mail: persis.amrolia@gosh.nhs.uk» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, multicohort, open-label, single-arm, Phase 2 study to assess the

efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases.

Participants will be enrolled in one of the following cohorts:

- EBV+ lymphoproliferative disease (LPD) in the setting of primary immunodeficiency (PID)

(EBV+ PID LPD) that is relapsed and/or refractory (R/R) or newly diagnosed where

standard first-line therapy is inappropriate

- EBV+ LPD in the setting of acquired (non-congenital) immunodeficiency (AID) (EBV+ AID

LPD) that is R/R or newly diagnosed where standard first-line therapy is inappropriate

- EBV+ posttransplant lymphoproliferative disease (PTLD) involving the central nervous

system (CNS) (EBV+ CNS PTLD) that is R/R or newly diagnosed where standard first-line

therapy is inappropriate

- EBV+ PTLD where standard first-line therapy (rituximab or chemotherapy) is

inappropriate, including cluster of differentiation antigen 20 (CD20)-negative disease

- EBV+ sarcomas, including leiomyosarcoma (LMS), or smooth muscle tumors that is rapidly

progressive where standard first-line therapy is inappropriate

Tabelecleucel will be administered in cycles lasting for 35 days. During each cycle,

participants will receive tabelecleucel at a dose of 2 x 10^6 cells/kg intravenously (IV)

weekly for 3 weeks, followed by observation through Day 35. Treatment will continue until

maximal response, disease progression, unacceptable toxicity, or initiation of nonprotocol

therapy for the underlying disease. For EBV+ sarcoma cohort, treatment will continue until

disease progression, unacceptable toxicity, two consecutive complete responses (CRs), or up

to 12 months from the first dose. Participants who fail to respond to initial tabelecleucel

treatment may continue tabelecleucel with a different human leukocyte antigen (HLA)

restriction (termed a Restriction Switch), if available; administration of tabelecleucel with

up to four different HLA restrictions is allowed for any participant.

After treatment is completed or discontinued, participants will complete a safety follow-up

visit at 30 days after the last dose and then will enter a quarterly follow-up period.

Participants without documented disease progression will be assessed every 3 months after the

safety follow-up visit for continued evaluation of disease response until the end of study

(EOS) visit at 24-month after first dose. Participants with disease progression any time

prior to the EOS visit will continue to be followed every 3 months for survival status until

the EOS visit.

An adaptive 2-stage design will be used for each cohort in this study. For each cohort, 8

evaluable participants will be enrolled in Stage 1. The decision to move to Stage 2

enrollment will be based on an interim analysis of the first 8 evaluable participants in the

cohort using investigator's assessment (per defined radiologic, clinical, and/or laboratory

response criteria) who receive tabelecleucel and have at least 1 valid postbaseline disease

response assessment. The number of participants enrolled in Stage 2 for each cohort will

depend on the number of observed responders in Stage 1. Sponsor may decide not to move

forward to Stage 2 in any cohort even if the criteria to move forward for that cohort are

met. The decision not to move forward may also be based on data from one or other cohorts.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of EBV+ disorder

- Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16

years; Lansky score >= 20 for participants from >=1 year to < 16 years

- Adequate organ function test results, unless organ dysfunction is considered to be due

to the underlying EBV-associated disease by the investigator

Cohort-specific Inclusion Criteria:

- For participants with PID LPD:

- R/R or newly diagnosed PID LPD for whom the standard first-line therapy is

inappropriate, as determined by investigator. The LPD is confirmed by at least

biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or

without radiographically measurable intracranial disease with EBV detected in

CSF.

- Participants with R/R disease must have had at least one prior line of systemic

therapy and one of the following: radiographic disease progression per Lugano

Classification (Cheson BD, et al. J Clin Oncol. 2014;27:3059) during or after

treatment or failure to achieve a CR or partial response (PR) (defined by Lugano

radiographic criteria) after standard first-line therapy

- Participant may have systemic disease only, systemic and CNS disease, or CNS

disease only

- For participants with AID LPD:

- R/R or newly diagnosed AID LPD for whom the standard first line therapy is

inappropriate, as determined by the investigator. The LPD is confirmed by at

least biopsy-proven EBV+ LPD or positive CSF cytology, with or without

radiographically measurable intracranial disease, with EBV detected in CSF.

- Participants with R/R disease must have had at least one prior line of systemic

therapy and one of the following: radiographic disease progression per Lugano

Classification during or after treatment or failure to achieve a CR or PR

(defined by Lugano radiographic criteria) after standard first-line therapy

- Participant may have systemic disease only, systemic and CNS disease, or CNS

disease only

- For participants with AID etiology or AID attributable to immunosenescence,

objective laboratory evidence of immunodeficiency

- For participants with CNS PTLD:

- R/R or newly diagnosed EBV+ CNS PTLD for whom the standard first-line therapy is

inappropriate, as determined by the investigator. The CNS PTLD is histologically

confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with

or without radiographically measurable intracranial disease with EBV detected in

CSF.

- Participants with R/R disease must have had at least one prior line of systemic

therapy and one of the following: radiographic disease progression per Lugano

Classification during or after treatment or failure to achieve a CR or PR

(defined by Lugano radiographic criteria) after standard first-line therapy

- Participant may have systemic and CNS disease or CNS disease only

- For participants with EBV+ PTLD, including CD20-negative disease:

- Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or

chemotherapy) is inappropriate, as determined by the investigator

- Participants must have systemic disease measurable per Lugano Classification

criteria, except when contraindicated or mandated by local practice, then MRI may

be used

- For participants with sarcoma, including LMS, or smooth muscle tumors:

- EBV+ sarcoma or smooth muscle tumor with rapidly progressive disease defined as

progressive disease per RECIST 1.1 criteria as documented radiographically within

a 6-month interval prior to enrollment

- Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line

therapy is inappropriate, as determined by the investigator

- Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically

confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor

- Measurable disease using diagnostic CT and/or MRI following RECIST 1.1 criteria

(Eisenhauer et al. 2009. Eur J Cancer 45[2]:228-247)

Exclusion Criteria:

- Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin,

plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or

other malignancies requiring systemic therapy

- Serious known active infections, defined as ongoing uncontrolled adenovirus infection

or infections requiring systemic therapy at the time of enrollment, or known history

of human immunodeficiency virus (HIV) infection

- Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the

Center for International Blood and Marrow Transplant Research (CIBMTR) consensus

grading system or extensive chronic GvHD per National Institutes of Health (NIH)

consensus criteria at the time of the enrollment

- Need for vasopressor or ventilatory support at the time of enrollment

- Prior therapy (in order of increasing washout period) prior to enrollment as follows:

- Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational

product and/ or any chemotherapy (systemic or intrathecal), targeted small

molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody

use is permitted within the washout period if a subsequent disease response

assessment indicates disease progression

- Within 8 weeks: prior tabelecleucel (>8 weeks prior to enrollment) is permitted

if response was obtained or if usual protocol-directed therapeutic options were

not exhausted, for cellular therapies (chimeric antigen receptor therapies

directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or

virus-specific T-cells); and/or therapies which could impact tabelecleucel

function (anti-thymocyte globulin, alemtuzumab)

- Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above

- Women who are breastfeeding or pregnant

- Unwilling to comply with protocol specified contraceptive/reproductive restrictions

from enrollment through 90 days after the last treatment

- Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid

equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants

with CNS disease, protocol-specified dexamethasone is permitted and concludes by the

time of enrollment)

- Any conditions that may put the study outcomes at undue risk (life expectancy < 60

days or any life-threatening illness, medical condition, or organ system dysfunction)

- For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid

organ transplant

- For participants with EBV+ PTLD: prior systemic therapy for PTLD

Studien-Rationale

Primary outcome:

1. Objective response rate (ORR) (Time Frame - Up to 2 years)



Secondary outcome:

1. Overall survival (OS) (Time Frame - Up to 2 years)

2. Duration of response (DOR) (Time Frame - Up to 2 years)

3. Progression-free survival (PFS) (Time Frame - Up to 2 years)

4. For EBV+ PID LPD cohort: Number of participants who reach definitive therapy (ie, allogeneic HCT) for the underlying disease (Time Frame - Up to 2 years)

5. For EBV+ PID LPD cohort: Time to definitive therapy (Time Frame - Up to 2 years)

6. For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: Clinical benefit rate (Time Frame - Up to 2 years)

7. For EBV+ sarcoma cohort, including LMS or smooth muscle tumors: ORR by immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria (Time Frame - Up to 2 years)

Studien-Arme

  • Experimental: EBV+ PID LPD
    Participants with R/R or newly diagnosed EBV+ PID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
  • Experimental: EBV+ AID LPD
    Participants with R/R or newly diagnosed EBV+ AID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
  • Experimental: EBV+ CNS PTLD
    Participants with R/R or newly diagnosed EBV+ CNS PTLD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.
  • Experimental: EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)
    Participants with EBV+ PTLD for whom standard first-line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease, will receive IV tabelecleucel.
  • Experimental: EBV+ sarcoma, including LMS, or smooth muscle tumors
    Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, including LMS or smooth muscle tumor, will receive IV tabelecleucel.

Geprüfte Regime

  • Tabelecleucel (tab-cel® / ATA129 / EBV-CTLs / ):
    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Quelle: ClinicalTrials.gov


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