Clinical trial · Interventional
Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
NCT04610125CI-TRIAL-00048005unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open, single-arm, prospective,clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auto CAR-T | Biological | — | UNRESOLVED |
| Cyclophosphamide,Fludarabine | Drug | — | UNRESOLVED |
| Leukapheresis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Auto CAR-T
- description
- Patients will be treated with Auto CAR-T cells
- interventionNames
- Biological: Auto CAR-T
- Drug: Cyclophosphamide,Fludarabine
- Procedure: Leukapheresis
Primary outcomes (2)
- measure
- Safety: Incidence and severity of adverse events
- timeFrame
- First month post CAR-T cells infusion
- description
- To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
- measure
- Efficacy: Remission Rate
- timeFrame
- 3 months post CAR-T cells infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.