- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778579
Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy (CART19-BE-02)
August 25, 2023 updated by: Sara V. Latorre
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
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Barcelona, Spain, 08036
- Hospital Clinic of Barcelona
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Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Murcia, Spain, 30120
- Hospital Clinico Universitario Virgen de La Arrixaca
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Salamanca, Spain, 37007
- Hospital Universitario de Salamanca
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Sevilla, Spain, 41013
- Hospital U. Virgen del Rocio
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias I Pujol
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Diagnoses of CD19+ acute lymphoid leukemia, with a life expectancy of less than 2 years that meet the following conditions:
- Relapsed/refractory not candidate for transplantation (due to associated diseases or absence of donor)
- in allogenic post-transplant relapse.
- Measurable disease understood as the presence of measurable residual disease by flow cytometry in bone marrow or peripheral blood
- Age less than 70 years (from 18 to 70).
- ECOG functional status from 0 to 2
- Life expectancy of at least 3 months.
- Adequate venous access to perform a lymphapheresis. Absence of contraindications for it.
- Signature of informed consent.
Exclusion Criteria:
- Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial.
- Previous treatment with CART therapy (commercial or experimental)
- 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.
- 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.
- Isolated extramedullary involvement (i.e. in the absence of minimal residual disease in peripheral blood, bone marrow, or cerebrospinal fluid)
- Early relapse after transplantation (less than 3 months for mononuclear cell apheresis, less than 6 months for infusion of ARI-0001)
- 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.
- Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
- HIV infection.
- 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
- Positive serology for hepatitis C, defined as a positive test for anti-VHC antibodies confirmed by RIBA
- 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.
- 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).
- Pregnant or lactating women. Woman of childbearing potential should have a negative pregnancy test in the screening phase.
- 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.
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
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ARI-0001
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 20 days after infusion
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• Response rate with measurable residual disease negative by multiparametric flow cytometry
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20 days after infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2021
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CART19-BE-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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