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Targeting CD19 chimeric antigen receptor gene modified autologous T cells (CD19 CAR-T) for the treatment of CD19 positive recurrent and refractory B cell malignancies

Targeting CD19 chimeric antigen receptor gene modified autologous T cells (CD19 CAR-T) for the treatment of CD19 positive recurrent and refractory B cell malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018902
Enrollment
Unknown
Registered
2018-10-16
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-10-22

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

Conditions

CD19 positive recurrent and refractory B cell malignancies

Interventions

Case series :infusion of cell

Sponsors

Department of Hematology, Wuxi people's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. CD19 positive recurrent and refractory B cell malignant hematologic malignancies; 2. Aged=70 years; 3. KPS score is more than 60 scores; 4. The absolute number of neutrophils is more than 1 x 10^9/L; 5. The absolute number of platelets is more than 75 x 10^9/L; 6. The absolute number of lymphocytes is more than 0.15 x 10^9/L; 7. The serum ALT is less than 100 U/L, and AST is less than 100 U/L; 8. Total bilirubin is less than 30 µmol; 9. Creatinine is less than 200 mol/L; 10. Women of childbearing age had negative urine pregnancy test before the start of the medication, and agreed to take effective contraceptive measures during the experimental period until the last follow-up; 11. Voluntary participation, good compliance, cooperate with experimental observation, and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Clinically, central nervous system leukemia (symptoms, signs, imaging, cerebrospinal fluid) can be found; 2. Patients with hyperleukaemia (white blood cell count > 50 x 10^9/L) or patients who were able to judge the progression of the disease quickly when they entered the group were unable to ensure a complete cycle of treatment; 3. Patients with infection including fungi, bacteria, viruses or other uncontrollable infections or four grade isolation treatment; 4. HIV, HBV, and HCV positive patients; 5. Patients with central nervous system diseases or autoimmune central nervous system diseases, including stroke, epilepsy, dementia, etc.; 6. In the first 12 months of the group were associated with myocardial infection, cardiac angiography or stent, active angina or other obvious clinical symptoms, or associated with CHD or cardiovascular lymphocytic infiltration; 7. Receiving anticoagulant therapy or severe coagulation disorders (APTT > 70); 8. According to the researchers' judgement, the drug treatment that the patient is receiving will affect the safety and effectiveness of the project; 9. Patients with allergy or allergy to biological agents used in this project; 10. Pregnant or lactating women; 11. Within 2 weeks before treatment, systemic and systemic steroid medications were used (except for inhaled steroids recently or currently being used); 12. Suffering from other uncontrolled diseases, the researchers consider it inappropriate for participants; 13. Researchers believe that any condition that may increase the risk or interfere with the outcome of the test may be increased; 14. Participated in other clinical studies.

Design outcomes

Primary

MeasureTime frame
complete remission;

Countries

China

Contacts

Public ContactYunfeng-Shen

Department of Hematology, Wuxi people's Hospital

yrbaijian@163.com+86 0510 82700775

Outcome results

None listed

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