CAR-T cell therapy for children with relapsed leukemia and lymphoma
Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
This study is testing a new CAR-T cell therapy to see if it can help children with relapsed leukemia and lymphoma feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Hebei Senlang Biotechnology Inc., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT04610125 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Auto CAR-T cell therapy in children aged 1-18 with relapsed or refractory hematopoietic and lymphoid tissue tumors. Participants will undergo a preconditioning treatment followed by CAR-T cell infusion, and will be monitored for adverse reactions and treatment effectiveness. The study aims to provide a new therapeutic option for this vulnerable patient population facing limited treatment alternatives.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-18 with confirmed relapsed or refractory hematopoietic and lymphoid tissue tumors.
Not a fit: Patients with severe cardiac or lung conditions, other advanced malignancies, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a potentially curative treatment option for children with difficult-to-treat cancers.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapies in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis; 3. Age: 1-18 years (including boundary value), both male and female; 4. Subjects with Lansky score ≥ 50; 5. The results of treatment-related antigens were positive; 6. The expected survival time is more than 3 months from the date of signing the informed consent. Exclusion Criteria: 1. Severe cardiac insufficiency and left ventricular ejection fraction \< 50%; 2. He had a history of severe lung function damage; 3. Combined with other advanced malignant tumors; 4. Severe infection was found and could not be effectively controlled; 5. With metabolic diseases (except diabetes mellitus); 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody \[HCV AB\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; 9. Severe allergy history of biological products (including antibiotics); 10. Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present; 11. The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.
Where this trial is running
Shijiazhuang, Hebei
- Pediatric hematology, Hebei Medical University Fourth Hospital — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Principal investigator: Lian Jiang, MD — Hebei Medical University Fourth Hospital
- Study coordinator: Jianqiang Li, PhD&MD
- Email: limmune@gmail.com
- Phone: 008615511369555
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.