Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children

Launched by HEBEI SENLANG BIOTECHNOLOGY INC., LTD. · Oct 29, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called CAR-T cell therapy for children with certain types of cancer, specifically leukemia and lymphoma, that have not responded to previous treatments or have come back after being treated. CAR-T therapy involves taking a patient's own immune cells, modifying them in the lab to better fight cancer, and then injecting them back into the patient. The goal is to see how effective and safe this treatment is for young patients aged 1 to 18 who meet specific health criteria.

To be eligible for this trial, children must have a confirmed diagnosis of relapsed or refractory hematopoietic or lymphoid tissue tumors and have the ability to participate in the study fully, including attending appointments and following the treatment plan. Participants should also have a certain level of health and expected survival time of at least three months. Throughout the trial, participants will receive treatment and may undergo various tests to monitor their response to the therapy and any side effects. It's important to note that some children may not qualify due to other health conditions, such as severe heart or lung issues, or active infections.

Gender

ALL

Eligibility 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.