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The PD-1 expression reduced by shRNA technology CD19 chimeric antigen receptor T cells (CAR-T) cells in the therapy of relapse or refractory lymphoma.

The PD-1 expression reduced by shRNA technology CD19 CAR-T cells in the therapy of relapse or refractory lymphoma.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018059
Enrollment
Unknown
Registered
2018-08-28
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

Relapse or refractory B-cells lymphoma

Interventions

Group 1:The PD-1 expression reduced by shRNA technology human source CD19 CAR-T cells therapy
Group 2:Human source CD19 CAR-T cells therapy

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his/her legal guardians must sign a consent form; 2. The patient ages 15 years to 80 years, male or female; 3. By pathology,imagingcell,morphology and flow cytometry analysis examination diagnosis of patients with B-cell lymphoma. Diagnosed as poor curative effect after standard treatment scheme or refractory B-cell lymphoma; 4. The patient has lesions which can be measured or evaluated; 5. Main organs seem to be functioning well: Liver function: bilirubin=34.2umol/L; Renal function: Serum creatinine<220umol/L; Lung function: arterial oxygen saturation=95%; Heart function: LVEF=40%; 6. Peripheral venous blood in patients flow smoothly; 7. Karnofsky score=60.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who want to be pregnant in 1 year; 3. Patients who can not use contraception in 1 year; 4. Uncontrolled active infection with in 4 weeks; 5. Active hepatitis B or hepatitis C virus infection; 6. HIV infected patients; 7. Patients with other cancers diagnosised by pathology; 8. Patients with serious autoimmune diseases or immunodeficiency; 9. Patients who suffer from allergies; 10. Patients who have taken part in other clinical tests within 6 weeks; 11. Patients who use systemic steroids before treatment within 4 weeks; 12. Patients who have a history of central nervous system disease; 13. Patients who are addicted to some drugs; 14. Patients who are not allowed to take part in the test(judged by the researchers).

Design outcomes

Primary

MeasureTime frame
Number of CAR-T infusion and transfection rate;Imaging methods (PET-CT, General diffusion MRI, or CT) would used to detect tumor progression and remission in patients with B-cell lymphoma;—

Secondary

MeasureTime frame
Adverse event observation;—

Countries

China

Contacts

Public ContactDeng Qi

Tiajin First Central Hospital

kachydeng@hotmail.com+86 13612055872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026