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Phase I study for the safety of different B-cell target CART cells in the treatment of recurrent and refractory mature B-cell lymphoma involving maxillofacial and / or central nervous system involvement

Phase I study for the safety of different B-cell target CART cells in the treatment of recurrent and refractory mature B-cell lymphoma involving maxillofacial and / or central nervous system involvement

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024457
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-07-03
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

recurrent and refractory mature B-cell lymphoma involving maxillofacial and / or central nervous system involvement

Interventions

experimental group:sequential B antigen chimeric antigen receptor T cells

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years 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. Aged 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;immune function;cytokines;complete remission rate;Progression-free survival (PFS);

Secondary

MeasureTime frame
erious adverse events;

Countries

China

Contacts

Public ContactZhang Yonghong

Beijing Boren Hospital

zhangyongh@borenhospital.com+86 13701251969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026