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

Launched by SARA V. LATORRE · Mar 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a type of blood cancer called CD19+ acute lymphoid leukemia, especially for those whose disease has not responded to previous therapies. The treatment involves infusing specially modified T-cells, which are a type of immune cell, to help the body fight the cancer. The main goal is to see how effective this treatment is in helping patients respond to therapy and how long those responses last.

To participate in the trial, patients need to be between 18 and 70 years old and have been diagnosed with CD19+ acute lymphoid leukemia that has either returned after treatment or did not respond to treatment at all. They should also have a life expectancy of at least three months and be able to provide informed consent. Participants can expect to undergo a process called lymphapheresis, where blood is drawn to collect their T-cells, which are then modified and infused back into their body. It's important to note that patients with certain health issues or recent treatments may not be eligible, and any ongoing infections or serious medical conditions would also be a concern for participation.

Gender

ALL

Eligibility 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
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