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Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy
EU CTIS ID: 2024-513601-31-00
What this study is testing
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
- 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
- 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) or 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
You likely can't join if
- Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial
- 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.
See the full eligibility 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) or 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
- Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial
- 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
- 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
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, 65+ years, 18-64 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.