Tests CD19 CAR T cell therapy in children with relapsed or refractory leukemia
Tests CD19 CAR T cells in children with returned or resistant B-cell acute leukemia.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
Key facts
- Where
- Tehran, IranSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 18 years old?
Source: NCT06635330, who can take part
Where in Iran
- Pediatric cell and gene therapy research center, Children medical centerTehran, IranTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kara Yakhteh Tajhiz Azma Company
- Trial code
- NCT06635330
- Record updated
- 10 October 2024
- Original description
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:Read full original descriptionShow less
A Phase I/II Single Arm Study, Safety and Efficacy Assessment of the CD19 CAR T Cell on Pediatric Patients with Relapsing or Refractory B Cell Acute Lymphoblastic Leukemia (r/r B-ALL)
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:
1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
Inclusion: Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL; Presence of disease in the bone marrow; Able to tolerate the apheresis process; Life expectancy \> 12 weeks; Lansky or Karnofsky score \> 50%; At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids; Informed consent; Having potential donor for stem cell transplantation.
Exclusion: Radiation therapy within last 14 days; Presence of active malignancy other than the disease under study; Any CNS disorder; History of Anti-CD19 or Anti-CD20 therapy; Presence of severe active infection; Donor lymphocyte injection or other cell therapy methods within the last 30 days; Chloroma and leukemic infiltration on MRI or significant neurological symptoms; Presence of active GVHD; Organ dysfunction.