A clinical study of chimeric antigen receptor T-cell immunotherapy in the treatment of CD19+ B-cell hematologic malignancies

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16008291

Enrollment

Unknown

Registered

2016-04-16

Start date

2016-04-01

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

B-cell hematologic malignancies

Interventions

1:CAR-T cells

Eligibility

Sex/Gender

All

Age

10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 10-70; 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. Previously treatment with any gene therapy products; 5. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 6. Patients with abnormal vital signs or could not cooperate with inspectors; 7. History of mental disorders; 8. Highly allergic constitution or severe allergies, especially allergic to IL-2; 9. Systemic infection or serious infections should be local anti-infection treatment; 10. With heart, lung, brain, kidney and other important organ dysfunction; 11. Presence of severe autoimmune disease; 12. Other situations we think improper for the research.

Design outcomes

Primary

Measure	Time frame
Complete remission rate;	—

Secondary

Measure	Time frame
Progression Free Survival;Overall Survival;Safety;	—

Countries

China

Contacts

Public ContactKailin Xu

The Affiliated Hospital of Xuzhou Medical College

lihmd@163.com+86 0516 85802398

Outcome results

None listed

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