A Phase 1/2 interventional study of anti-CD19 CAR T cell therapy in Relapse/Refractory B-cell Acute Lymphoblastic Leukemia, sponsored by Kara Yakhteh Tajhiz Azma Company. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Kara Yakhteh Tajhiz Azma Company · Phase 1/2, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:
B-cell acute lymphoblastic leukemia (B-ALL), as the most common type of pediatric tumor, is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood. Also, relapse and refractory B-ALL (R/R B-ALL) is the main reason of global mortality due to the constraints of combination chemotherapy.
Over the past few years, substantial advancements have been made in treatment of ALL, specifically in the R/R context. Chimeric antigen receptor T (CAR-T) cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface. CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of r/r B-ALL. In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with R/R B-ALL.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 5 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →This is the only study on the registry with Kara Yakhteh Tajhiz Azma Company as lead sponsor.
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Exclusion Criteria:
Biological: anti-CD19 CAR T cell therapy
Anti-CD19 CAR-T cell therapy for R/R B-ALL pediatric patients. For patients 50 kg and less: 0.2 to 5 in ten to the power of six live CAR+ T cells per kilogram of body weight/ For patients over 50 kg: 0.1 to 2.5 in ten to the power of eight live CAR+ T cells (without considering weight).
Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)
Time frame: First month and 2-3 months after intervention
Overall survival
Time frame: First month and 3 months after intervention
Incidence of cytokine release syndrome: grade 3 and 4
Time frame: First month and 3 months after intervention
Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4
Time frame: First month and 3 months after intervention
Event-free survival
Time frame: First month and 2-3 months after intervention
Percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)
Time frame: 6 months and 12 months after intervention
Investigation of Minimal residual disease in patient
Time frame: First month and 2-3 months after intervention
Incidence of cytokine release syndrome: grade 3 and 4
Time frame: 6 months and 12 months after intervention
Incidence of Immune effector cell-associated neurotoxicity syndrome (ICANS): grade 3 and 4
Time frame: 6 months and 12 months after intervention
Incidence of tumor lysis syndrome (TLS)
Time frame: Months 1, 3, 6, and 12 after the intervention
Incidence of leukopenia
Time frame: Months 1, 3, 6, and 12 after the intervention
Incidence of infection
Time frame: Months 1, 3, 6, and 12 after the intervention
Event-free survival
Time frame: 6 months and 12 months after intervention
Overall survival
Time frame: 6 months and 12 months after intervention
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