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A clinical trial of CAR-T cell therapy

A clinical trial of CAR-T cell therapy for relapsed and refractory CD19+ acute leukemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCC-15007008
Enrollment
Unknown
Registered
2015-08-24
Start date
2015-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

leukemia

Interventions

CAR-T group:CAR-T therapy

Sponsors

Bone marrow transplantation center,first affiliated hospital of Zhejiang University,school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. CD19 positive acute leukemia: (1) cases of CD19 positive ALL/lymphoma with relaps, refractoriness or durg risistence; (2) high tumor load before aHSCT; (3) failed DLI for relapse after aHSCT; (4) relapsed refractory MRD positive cases; (5) extramedullary leukemia failed for chemotherapy/radiotherapy; 2. aged 0-60; 3. expected survival beyond 6 months; 4. urine pregnancy test negative for fertile women,and agree to take contraception during the trial; 5. voluntarily anticipated the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. medical history of epilepsy or other disease of central nervous system; 2. case of GVHD using immunosuppressant; 3. medical history of prolonged QT period or other severe heart disease; 4. pregnancy or lactation; 5. uncured active infection; 6. active HBV/HCV infected; 7. steroid drug users in 2 weeks; 8. gene therapy product ever used; 9. transfection efficiency lower than 30%, or low amplification (2.5mg/dl or ALT/AST>3 fold standard value or bilirubin>2.0 mg/dl; 11. any uncured disease considered unavailable for the trial; 12. HIV infected; 13. any condition may increase volunteer's risk or interference the outcome of the trial.

Design outcomes

Primary

MeasureTime frame
minimal residual diseas;remission rate;

Countries

China

Contacts

Public ContactHe Huang
huanghe@zju.edu.cn+86 13605714822

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026