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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 children and adolescents aged 0-18 years with CD19+ acute lymphoblastic leukaemia resistant or refractory to treatment.
EU CTIS ID: 2024-515467-66-00
What this study is testing
To evaluate the efficacy (response rate) of ARI-0001 cells in paediatric patients with CD19+ acute lymphoblastic leukaemia that is resistant or refractory to therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 0 to 18 years
- Diagnosis of relapsed /refractory CD19+ ALL defined as at least one of the following criteria: • First relapse if high-risk features. Definition of high risk 1st relapse will include at least one of the following: o any relapse before 6 months after completion of chemotherapy o high risk cytogenetics: t(4;11)(q21; q23) /AF4:: KMT2A or t (1;19) (q23; p13) / TCF3/PBX or t(17;19) (q22;p13)/ TCF3::HLF or hypodiploid (<44 chromosomes) or TP53 mutation and/ or TP53 deletion
- Disease burden defined as: • Morphologic relapse in bone marrow (≥5% blasts) or presence of leukemic blasts in an extramedullary site • MRD positivity (≥0.01%) by flow cytometry or PCR
- Subjects with the following features are NOT excluded: • Isolated extramedullary involvement • Down syndrome patients • CNS3 involvement if disease is stable and a thorough evaluation of risk/benefit assessment has been stablished by the principal investigator and the treating physician • Ph+ (BCR::ABL1) ALL if they are intolerant or have failed at least 1 TKI • Prior blinatumomab therapy provided blasts remain CD19+ >90% blasts at inclusion
- Performance status: Lansky (age <16 years) or Karnofsky (age ≥16 years) ≥ 50%
- Life expectancy >3 months
You likely can't join if
- Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer
- Lactating or pregnant women
- Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures during the study
- Active immunosuppressive therapy with the exception of hydrocortisone 12 mg/m2/day (or equivalent);
- Active acute or chronic graft versus host disease (GVHD) >grade 1
- Prior therapies: • CAR-T cell therapy • Donor lymphocytes infusion <28 days before enrollment • Immunosuppressive therapy (cyclosporine, mophetil mycophenolate and others) must be stopped <14 days before enrollment • Alentuzumab, thymoglobulin (ATG) < 3 months before enrollment
See the full eligibility criteria
Who can join
- Age 0 to 18 years
- Diagnosis of relapsed /refractory CD19+ ALL defined as at least one of the following criteria: • First relapse if high-risk features. Definition of high risk 1st relapse will include at least one of the following: o any relapse before 6 months after completion of chemotherapy o high risk cytogenetics: t(4;11)(q21; q23) /AF4:: KMT2A or t (1;19) (q23; p13) / TCF3/PBX or t(17;19) (q22;p13)/ TCF3::HLF or hypodiploid (<44 chromosomes) or TP53 mutation and/ or TP53 deletion
- Disease burden defined as: • Morphologic relapse in bone marrow (≥5% blasts) or presence of leukemic blasts in an extramedullary site • MRD positivity (≥0.01%) by flow cytometry or PCR
- Subjects with the following features are NOT excluded: • Isolated extramedullary involvement • Down syndrome patients • CNS3 involvement if disease is stable and a thorough evaluation of risk/benefit assessment has been stablished by the principal investigator and the treating physician • Ph+ (BCR::ABL1) ALL if they are intolerant or have failed at least 1 TKI • Prior blinatumomab therapy provided blasts remain CD19+ >90% blasts at inclusion
- Performance status: Lansky (age <16 years) or Karnofsky (age ≥16 years) ≥ 50%
- Life expectancy >3 months
- Adequate venous access and no contraindications for lymphoapheresis
- Signature of informed consent (patient and/or legal guardian)
What rules you out
- Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer
- Lactating or pregnant women
- Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures during the study
- Active immunosuppressive therapy with the exception of hydrocortisone 12 mg/m2/day (or equivalent);
- Active acute or chronic graft versus host disease (GVHD) >grade 1
- Prior therapies: • CAR-T cell therapy • Donor lymphocytes infusion <28 days before enrollment • Immunosuppressive therapy (cyclosporine, mophetil mycophenolate and others) must be stopped <14 days before enrollment • Alentuzumab, thymoglobulin (ATG) < 3 months before enrollment
- Active infection that is uncontrolled or requiring systemic intravenous medical therapy;
- Any experimental or non-commercialized therapy in the previous 4 weeks
- Active HIV, HBV or HCV infection
- Any concomitant and uncontrolled medical or psychiatric disease that, under investigator consideration, would prevent the subject from participating in the study
- Severe organic impairment defined by cardiac ejection fraction <50%, pulmonary reserve defined as > Grade 1 dyspnea and pulse oxygenation <91% on room air, creatinine >1.5 times greater than the upper limit of normality (ULN) for sex and age or conjugated bilirubin >2 x ULN
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.