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Evaluation of the safety and efficacy of CD19 CAR-T cells therapy for Refractory/Relapse Central Nervous System Diffuse Large B-cell Lymphoma

Evaluation of the safety and efficacy of multiple target gene modified T cells therapy for Refractory/Relapse Hematological Malignancy ---Single center, single arm, open clinical study

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000028781
Enrollment
Unknown
Registered
2020-01-03
Start date
2019-10-21
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Hematological malignancy

Interventions

Sponsors

The Third Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 2 to 70 years, the expected survival time >3 months; 2. By immunophenotypic analysis, CD19 was positive; 3. ECOG score =2.0x10^9/L; Lymphocyte count>0.5x10^9/L; Hb >=80 g/L, PLT >=30x10^9/L); 6. Non-severe allergic constitution; 7. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that conflict with this program; 8. No history of other malignant tumors; 9. Women of childbearing age must have a negative blood pregnancy test within 7 days and must use appropriate contraception during the study and for 3 months after the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing women (women of childbearing age need to have a pregnancy test); 2. Severe infectious or viral diseases (HIV positive, syphilis, etc.); 3. Active viral hepatitis b or c; 4. Patients who had used amounts of glucocorticoids within 1 week; 5. Patients with severe heart, liver, renal insufficiency, diabetes and other diseases; 6. Those who have participated in other clinical studies in the past 3 months or have previously received other gene product treatments.

Design outcomes

Primary

MeasureTime frame
CAR gene;

Countries

China

Contacts

Public ContactXun Lai

The Third Affiliated Hospital of Kunming Medical University

1729112214@qq.com+86 13577096609

Outcome results

None listed

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