Skip to content

Clinical trial of safety and efficacy of CD19 chimeric antigen receptor T cell in the treatment of refractory/relapsed positive B-cell malignant lymphoma

Clinical trial of safety and efficacy of CD19 chimeric antigen receptor T cell in the treatment of refractory/relapsed positive B-cell malignant lymphoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058318
Enrollment
Unknown
Registered
2022-04-05
Start date
2022-04-20
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

refractory/relapsed positive CD19+ B-cell malignant lymphoma

Interventions

Experimental group:infuse 2.0x10^6 CAR+ T Cells/kg

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically diagnosed as CD19-positive B-cell non-Hodgkin's lymphoma; 2. Aged 15-80 years; 3. Meet one of the following three conditions: (1) Patients with relapsed or refractory B-cell lymphoma treated with a standard chemotherapy regimen and a salvage regimen with rituximab or another CD20 antibody drug and at least two chemotherapy regiments appropriate for their disease, one of which should include anthracyclines; Patients maintained or progressed SD(SD duration =12 weeks; 5. Good heart, liver and kidney function: (1) Serum creatinine = 50%, cardiac ultrasound showed centerless effusion; 6. Eastern Oncology Collaborative Group Activity Status Score (EOCG)0-3; 7. Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Have uncontrolled infection; 3. Active hepatitis B or C; 4. Patients who had used steroid hormones within 1 week before transfusion; 5. Patients who had used rituximab two weeks before transfusion; 6. Lesions of central nervous system that cannot be controlled by drugs; 7. Hiv-infected patients; 8. Other diseases that may conflict with this clinical study, including cardiovascular, neurological and psychiatric diseases.

Design outcomes

Primary

MeasureTime frame
CD19+Bcell;Peripheral blood CAR T+ cells;

Secondary

MeasureTime frame
Remission rate of lymphoma;

Countries

China

Contacts

Public ContactWang Liang
wangliangtrhos@126.com+86 15001108693

Outcome results

None listed

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