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Phase II clinical study for the safety of sequential BART target CART cells in the treatment of relapsed and refractory B-cell lymphoma involving maxillofacial and / or central nervous system

Phase II clinical study for the safety of sequential BART target CART cells in the treatment of relapsed and refractory B-cell lymphoma involving maxillofacial and / or central nervous system

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000031013
Enrollment
Unknown
Registered
2020-03-21
Start date
2020-03-16
Completion date
Unknown
Last updated
2020-03-23

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

Case series:Sequential input of CART cells to different B cell targets

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed B-cell tumors with positive target markers, primary drug resistance, tumor progression, recurrence during chemotherapy or tumor recurrence after discontinuation, no response for 1 course of chemotherapy, and partial remission cannot be obtained (standard refer to NCCN guidelins, version 4, 2014) or chemotherapy 2 course can not achieve complete remission; 2. Maxillofacial or central involvement (including cerebrospinal fluid where tumor cells can be found, intracranial tumor mass, spinal cord mass, etc.); 3. Aged 1-18 years; 4. Patients under 18 years of age have self-knowledge and can sign informed and voluntary consent forms; 5. The child patient's guardian or patient trustee signed the informed and voluntary consent form and joined the trial.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure 4. With other types of malignant tumors; 5. Diffuse intravascular coagulation; 6. Serum creatinine and / or urea nitrogen = 1.5 times the normal value; 7. Sepsis or other difficult to control infections; 8. Uncontrollable diabetes; 9. Severe mental disorder; 10.WHO physical status classification >=3; 11. Organ transplant recipients; 12. The total number of CART cells after culture does not reach the infusion standard.

Design outcomes

Primary

MeasureTime frame
diameter of turmor;blood cell account;immune function;cytokines;complete remission rate;Progression-free survival (PFS);

Countries

China

Contacts

Public ContactYonghong Zhang

Beijing Boren Hospital

zhangyongh@borenhospital.com+86 13701251969

Outcome results

None listed

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