Skip to content

A clinical trial for safety and efficient of CD19CART cells combination with nivolumab in the treatment of refractory/relapsed B cell lymphoma

A clinical trial for safety and efficient of CD19CART cells combination with nivolumab in the treatment of refractory/relapsed B cell lymphoma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019288
Enrollment
Unknown
Registered
2018-11-03
Start date
2017-01-01
Completion date
Unknown
Last updated
2020-10-13

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

1:CD19CART combined with anti-PD-1 antibody
2:CD19CART

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patient or his/her legal guardians must sign a consent form; 2. patient aged 5 years to 80 years male or female; 3. patient was diagnosed with B-cell lymphoma by pathology, histology and flow cytometry; 4. patient has lesions which can be measured or evaluated; 5. main organs seem to be normal functioning: 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
remission rate;amplification and duration of CART;Imaging examination (PET-CT,CT or B-ultrasound) to detect the tumor burden in patients with B-cell lymphoma;

Countries

China

Contacts

Public ContactMingfeng Zhao

Department of hematology, Tianjin First Central Hospital

mingfengzhao@sina.com+86 13752640369

Outcome results

None listed

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