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Clinical study of humanized CD19 CAR-T in the treatment of newly diagnosed adult acute lymphoblastic leukemia

Clinical study of humanized CD19 CAR-T in the treatment of newly diagnosed adult acute lymphoblastic leukemia

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017401
Enrollment
Unknown
Registered
2018-07-28
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

acute lymphoblastic leukemia

Interventions

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Expected survival beyond 12 weeks; 3. Patients with acute lymphoblastic leukemia diagnosed by pathology and histology; 4. Patients have contraindications to chemotherapy or transplantation or refuse to undergo chemotherapy and hematopoietic stem cell transplantation; 5. Creatinine 50; 9. Patients without severe liver, kidney, heart disease; 10. Venous blood could be obtained or no contraindications for white blood collection; 11. Patients can understand and voluntarily sign informed consent.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Complete remission rate;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