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Phase I study of sequential B antigen chimeric antigen receptor T cells treating refractory and relapsed mature B cell Lymphoma in children and young adolescents

Phase I study of sequential B antigen chimeric antigen receptor T cells treating refractory and relapsed mature B cell Lymphoma in children and young adolescents

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014457
Enrollment
Unknown
Registered
2018-01-15
Start date
2018-01-14
Completion date
Unknown
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphoma

Interventions

Case series:sequential B antigen chimeric antigen receptor T cells

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: patient's pathology was confirmed as mature BCL with positive target markers, tumor progression or relapse happened during chemotherapy; or tumor recurred after stopping chemotherapy, and there was no efficacy after one course of chemotherapy and partial remission could not be obtained (refer to NCCN guidelins, version 4, 2014) or complete remission can not be achieved after 2 courses of treatment.Age 1-18 years; patients <18 years of age have the ability to sign consent; the guardian of the patient or patient delegate signed consent before joining the trial.

Exclusion criteria

Exclusion criteria: Intracranial hypertension or confusion; Symptomatic heart failure or severe arrhythmia; Respiratory failure; With other types of malignancy; Diffuse intravascular coagulation; Serum creatinine and / or urea nitrogen = 1.5 times normal value; Sepsis or other uncontrollable infections; Uncontrolled diabetes; Serious mental disorder; Skull MRI obvious intracranial lesions; CSF examination leukemia cells> 20/ul; The proportion of blood leukemia cells> 30%; WHO physical status graded =3; Organ Transplant Recipients; Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
diameter of turmor;blood cell account;blood biochemistry;immune function;cytokines;flow cytometry;

Countries

China

Contacts

Public ContactYong-hong Zhang

Beijing Boren Hospital

yhzhang58@hotmail.com+86 18611755567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026