Evaluating CAR T Cell Therapy for Pediatric B-ALL
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)
This study is testing a new treatment using modified immune cells to see if it can help children with tough cases of leukemia feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Kara Yakhteh Tajhiz Azma Company Research network |
| Drugs / interventions | chemotherapy, Radiation, CAR-T, CAR T, Chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Tehran, Tehran Province) |
| Trial ID | NCT06635330 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of CD19 CAR T cell therapy in children aged 2 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The study will measure the overall remission rate, event-free survival, and overall survival at specified intervals post-treatment. By modifying patient T cells to target CD19, the trial seeks to improve outcomes for this challenging pediatric cancer. The study will involve apheresis to collect T cells, which will then be engineered and reintroduced to the patient.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 18 years with relapsed or refractory CD19+ B-ALL who meet specific health criteria.
Not a fit: Patients with active malignancies other than B-ALL or significant neurological disorders may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could significantly improve remission rates and survival outcomes for children with r/r B-ALL.
How similar studies have performed: Previous studies have shown promising results with CAR T cell therapy in treating r/r B-ALL, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Presence of active malignancy other than the disease under study * Chloroma and leukemic infiltration on MRI or significant neurological symptoms * Any CNS disorder * Presence of active GVHD * Radiation therapy within last 14 days * History of Anti-CD19 or Anti-CD20 therapy * Donor lymphocyte injection or other cell therapy methods within the last 30 days * Presence of severe active infection * Organ dysfunction
Where this trial is running
Tehran, Tehran Province
- Pediatric cell and gene therapy research center, Children medical center — Tehran, Tehran Province, Iran (Recruiting)
Study contacts
- Study coordinator: Setayesh Sadeghi
- Email: sadeghi.setayesh@gmail.com
- Phone: +989124779968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.