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Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy (CART19-BE-02)

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ClinicalTrials.gov Identifier: NCT04778579
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : July 28, 2022
Sponsor:
Collaborators:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Sara V. Latorre, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Study Description
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Brief Summary:
To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated to the 4-aBB and CD3z co-stimulatory regions) in patients with resistant or refractory CD19+ acute lymphoid leukemia

Condition or disease Intervention/treatment Phase
Acute Lymphoid Leukemia Drug: ARI-0001 cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity (A3B1) Conjugated With the Co-stimulatory Regions 4-1BB and CD3z (ARI-0001 Cells) in Patients With CD19+ Acute Lymphoid Leukemia Resistant or Refractory to Therapy
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ARI-0001
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
 Drug: ARI-0001 cells
Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z
Other Names:
  • CART19
  • PEI 19-187


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 20 days after infusion ]
    • Response rate with measurable residual disease negative by multiparametric flow cytometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnoses of CD19+ acute lymphoid leukemia, with a life expectancy of less than 2 years that meet the following conditions:

    1. Relapsed/refractory not candidate for transplantation (due to associated diseases or absence of donor)
    2. in allogenic post-transplant relapse.
  2. Measurable disease understood as the presence of measurable residual disease by flow cytometry in bone marrow or peripheral blood
  3. Age less than 70 years (from 18 to 70).
  4. ECOG functional status from 0 to 2
  5. Life expectancy of at least 3 months.
  6. Adequate venous access to perform a lymphapheresis. Absence of contraindications for it.
  7. Signature of informed consent.

Exclusion Criteria:

  1. Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial.
  2. Previous treatment with CART therapy (commercial or experimental)
  3. Diagnosis of another neoplasm, past or present. Patients may be included in complete remission for more than 3 years, or have a history of non-melanoma skin cancer or in-situ carcinoma resected completely.
  4. Relief of central nervous system (CNS-3) at the time of inclusion. Inclusion will be permitted in patients with a lower grade (CNS-2) or CNS-3 who have responded to intrathecal chemotherapy.
  5. Isolated extramedullary involvement (i.e. in the absence of minimal residual disease in peripheral blood, bone marrow, or cerebrospinal fluid)
  6. Early relapse after transplantation (less than 3 months for mononuclear cell apheresis, less than 6 months for infusion of ARI-0001)
  7. Active immunosuppressive treatment for graft-versus-host disease and other diseases. The use of corticosteroids to control leukaemia at the time of inclusion should be limited as much as possible and should be discontinued prior to infusion of ARI-0001 cells.
  8. Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
  9. HIV infection.
  10. Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies it will be necessary to perform a DNA test of the hepatitis B virus, and if the result is positive the patient will be excluded
  11. Positive serology for hepatitis C, defined as a positive test for anti-VHC antibodies confirmed by RIBA
  12. Concurrent uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric diseases that in the opinion of the investigator are potential risk factors to the patient.
  13. Severe organ involvement, defined as cardiac ejection fraction <40%; DLCO <40%; calculated glomerular filtrate <30 ml/min; or bilirubin > 3 times the upper limit of normality (unless Gilbert syndrome).
  14. Pregnant or lactating women. Woman of childbearing potential should have a negative pregnancy test in the screening phase.
  15. Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods* from the start of the study to the completion of the study.

  16. Men who cannot or do not wish to use highly effective contraceptive methods* from the beginning of the study until the end of the study

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778579


Contacts
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Contact: Jordi Esteve +34932275400 jesteve@clinic.cat
Contact: Valentín Ortiz-Maldonado vortiz@clinic.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Anna Torrent Catarineu, MD, PhD       atorrent@ioncologia.net   
Principal Investigator: Anna Torrent         
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Jose J Rifón, MD PhD       jrifon@unav.es   
Principal Investigator: José J Rifón         
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Jordi Esteve, MD PhD    +34932275400    jesteve@clinic.cat   
Contact: Valentín Ortiz-Maldonado, MD    +34932275400    vortiz@clinic.cat   
Principal Investigator: Jordi Esteve         
Principal Investigator: Valentín Ortiz Maldonado         
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08041
Contact: Javier Briones Meijide       jbriones@santpau.cat   
Principal Investigator: Javier Briones Meijide         
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Contact: Mi L Kwon, MD, PhD       mi.kwon@salud.madrid.org   
Sub-Investigator: José L Díez Martín         
Principal Investigator: Mi Kwon         
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Maria L Paciello Coronel, MD, PhD       mariapaciello@hotmail.com   
Principal Investigator: Maria L Paciello         
Hospital Clínico Universitario Virgen de La Arrixaca Recruiting
Murcia, Spain, 30120
Contact: Jose M Moraleda, MD PhD       jmoraled@um.es   
Principal Investigator: Jose M Moraleda         
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Dolores Caballero, MD PhD       cabarri@usal.es   
Principal Investigator: Dolores Caballero         
Hospital U. Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Cristina Blázquez       cristinablazquezgoni@gmail.com   
Principal Investigator: Cristina Blazquez         
Hospital La Fe Withdrawn
Valencia, Spain, 46026
Sponsors and Collaborators
Sara V. Latorre
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Salud Carlos III
More Information
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Responsible Party: Sara V. Latorre, Clinical Research Manager, Institut d'Investigacions Biomèdiques August Pi i Sunyer
ClinicalTrials.gov Identifier: NCT04778579    
Other Study ID Numbers: CART19-BE-02
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases