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An open single center single arm clinical study of t fully human anti-CD19 CAR-T therapy for CD19+ B-cell hematologic malignancies

An open single center single arm clinical study of t fully human anti-CD19 CAR-T therapy for CD19+ B-cell hematologic malignancies

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011271
Enrollment
Unknown
Registered
2017-05-01
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-05-09

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

Conditions

B-cell hematologic malignancies

Interventions

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5-70 years; 2. Expected survival beyond 12 weeks; 3. Patients with CD19+ hematologic malignancies diagnosed by pathology and histology; 4. Patients could not achieve complete response after chemotherapy; 5. Patients with with relapsed disease after chemotherapy; 6. Creatinine 50; 10. Patients without severe liver, kidney, heart disease; 11. Patients with relapsed disease after hematopoietic stem cell transplantation; 12. Not eligible or appropriate for hematopoietic stem cell transplantation; 13. Voluntary participation in the clinical trials; 14. Venous blood could be obtained or no contraindications for white blood collection; 15. Sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected; 3. Active hepatitis B or hepatitis C infection; 4. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 5. Patients with abnormal vital signs or could not cooperate with inspectors; 6. History of mental disorders; 7. Highly allergic constitution or severe allergies, especially allergic to IL-2; 8. Systemic infection or serious infections should be local anti-infection treatment; 9. With heart, lung, brain, kidney and other important organ dysfunction; 10. Presence of severe autoimmune disease; 11. Other situations we think improper for the research.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Secondary

MeasureTime frame
Progression Free Survival;Overall Survival;Safety;

Countries

China

Contacts

Public ContactKailin Xu

The Affiliated Hospital of Xuzhou Medical University

lihmd@163.com+86 0516 85802398

Outcome results

None listed

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