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Experimental and clinical research of targeted CD19 CAR - T cells treatment for refractory or recurrence B lymphocyte leukemia/lymphoma

Experimental and clinical research of targeted CD19 CAR - T cells treatment for refractory or recurrence B lymphocyte leukemia/lymphoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014248
Enrollment
Unknown
Registered
2018-01-02
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-08

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

Conditions

B cell leukemia/lymphoma

Interventions

Case series:therapy by CART

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. disease diagnosis: (1) Recurrent refractory B cell lymphoma (CD19 positive); (2) Recurrent refractory chronic lymphocytic leukemia (CD19 positive); (3) recurrent refractory acute B lymphocytic leukemia (CD19 positive). 2. Aged 16-80 years old; 3. Predict the survival period > 12 weeks; 4. Patients with unintentional liver and renal insufficiency; 5. Peripheral blood extraction can be performed and isolated peripheral blood cell (PBMCs) can be activated by CD3 /CD28 antibody and can be amplified in vitro; 6. Patients who have received allogeneic hematopoietic stem cell transplantation should be after the recovery period of 6 months. No obvious graft versus host disease, and dependence on immunosuppressive therapy; 7. Patients with no significant CD19 positive b-all caused central nervous system symptoms (such as meningeal leukemia); 8. No uncontrollable activity period infection, no active period HBV, HCV and HIV infection; 9. If a patient is a woman of reproductive period, she should be excluded from pregnancy and effective contraception during treatment; 10. Untreated steroids (such as hormone) were not used in three months; 11. No other gene therapy drugs or agents have been received.

Exclusion criteria

Exclusion criteria: 1. Prediction of survival <12 weeks; 2. Patients with cardiac renal insufficiency; 3. The symptoms of central nervous system (such as meningeal leukemia) caused by the obvious CD19 positive b-all. 4. Active stage infection, HBV, HCV and HIV infection; 5. Have received any other gene therapy drugs and preparations.

Design outcomes

Primary

MeasureTime frame
Response rate;

Countries

China

Contacts

Public ContactTAN HUO

The First Affiliated Hospital of Guangzhou Medical University

tanhuo.2008@163.com+86 02034293776

Outcome results

None listed

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