CAR-T cell therapy for children and young adults with relapsed leukemia or lymphoma
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
PHASE1 · Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · NCT05333302
This study is testing a new CAR-T cell therapy to see if it can help children and young adults with leukemia or lymphoma that hasn't responded to other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Sponsor | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology (other) |
| Drugs / interventions | CAR-T, immunotherapy, tocilizumab, cyclophosphamide, fludarabine |
| Locations | 1 site (Minsk, Minsk Oblast) |
| Trial ID | NCT05333302 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of second generation autologous CD19 CAR-T cell immunotherapy in children and young adults suffering from relapsed or refractory acute lymphoblastic leukemia or lymphoblastic B-cell lymphoma. Participants will undergo lymphodepleting conditioning with fludarabine and cyclophosphamide, followed by an intravenous infusion of CAR-T cells, with tocilizumab administered as premedication. The goal is to assess how well this treatment can help patients who have not responded to standard therapies.
Who should consider this trial
Good fit: Ideal candidates include children and young adults with CD19+ relapsed or refractory lymphoblastic leukemia or lymphoma who meet specific health criteria.
Not a fit: Patients with primary immunodeficiencies, severe neurological diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, effective treatment option for children and young adults with difficult-to-treat leukemia and lymphoma.
How similar studies have performed: Other studies using CAR-T cell therapy have shown promising results in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma; * Karnofsky or Lansky performance scale greater or equal to 70; * T-cells count in peripheral blood \>150 cells/µL; * Written informed consent. Exclusion Criteria: * primary immunodeficiencies or genetic syndromes; * neurologic diseases; * autoimmune diseases or polyallergie; * transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion; * GvHD grade 2-4; * uncontrolled systemic infection; * hypoxia (Sp02\<90%) * severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age; * renal dysfunction: serum creatinine level \>=3x upper limit of normal for age; * positive serology for human immunodeficiency virus (HIV), active hepatite C or B; * pregnancy.
Where this trial is running
Minsk, Minsk Oblast
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk, Minsk Oblast, Belarus (RECRUITING)
Study contacts
- Study coordinator: Elena Lukoyko, MD
- Email: lenalukojko@gmail.com
- Phone: +375291643075
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.
Conditions: B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma, immunotherapy, CAR-T cells, CD19