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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
ChiCTR2000034575
Enrollment
Unknown
Registered
2020-07-10
Start date
2020-08-30
Completion date
Unknown
Last updated
2020-07-20

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

Low dose level:infuse 1.0×10^6 CAR+ T Cells/kg
High dose level:infuse 1.0×10^7 CAR+ T Cells/kg

Sponsors

Hebei Yanda Lu Daopei Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histopathological diagnosis as CD19-positive B-cell non-Hodgkin's lymphoma; 2. Age between 3-80 years old; 3. Meet one of the following three situations, all can be included (1) Patients who have received a standard chemotherapy regimen and a rescue regimen for patients with relapsed or refractory B-cell lymphoma. The chemotherapy regimen is rituximab or other CD20 antibody drugs and at least two types of chemotherapy suitable for their disease Protocol, one of the chemotherapy should include anthracycline antibiotics; after these regimens, the patient maintains SD (SD duration = 50%, cardiac ultrasound showed no pericardial effusion. 6. US Eastern Cooperative Oncology Group (ECOG) Scale of Performance <= 3 points; 7. The patient can understand and voluntarily sign the informed consent form; if the subject is a child, the guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing woman 2. Uncontrolled infection 3. Active hepatitis B or hepatitis C 4. Patients who used steroids within a week before cell infusion 5. Patients who used merova within two weeks before cell infusion 6. Drug-uncontrollable central nervous system lesions 7. HIV infected patients 8. Other diseases that conflict with this study, including cardiovascular, neurological, psychiatric disorders, etc.

Design outcomes

Primary

MeasureTime frame
PBMC CAR-T+Tcell, CD19+Bcell;remission rate of lymphoma;

Countries

China

Contacts

Public ContactXian Zhang

Hebei Yanda Lu Daopei Hospital

zhxian2@126.com+86 13641041596

Outcome results

None listed

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