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A clinical study of chimeric-antigen-receptor-tranduced T cells in the treatment of B-cell hematologic malignancies

A clinical study of chimeric-antigen-receptor-tranduced T cells in the treatment of B-cell hematologic malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17011211
Enrollment
Unknown
Registered
2017-04-21
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-24

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 Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: Meet the following conditions of CD19 positive patients with acute lymphocytic leukemia or lymphoma: 1. History of the treatment: 1) Recurrence of B-cell lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of acute B-cell leukemia patients, after chemotherapy or stem cell transplantation; 2) Can't get complete remission after more than twice repeated chemotherapy of B-cell lymphoma or acute B-cell leukemia patients; 3) Can't get remission after one or twice chemotherapy, also not suitable for chemotherapy of acute B-cell leukemia patients. 2. ECOG score=2; 3. To be aged 1 to 70 years; 4. More than a month lifetime from the consent signing date.

Exclusion criteria

Exclusion criteria: 1. Serious cardiac insufficiency, left ventricular ejection fraction<50; 2. Has a history of severe pulmonary function damaging; 3. Merging other malignant tumor; 4. Merging uncontrolled infection; 5. Merging the metabolic diseases (Except for diabetes); 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis B or hepatitis C; 8. patients with HIV infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients 11. Pregnancy or lactation women; 12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;overall response rate;Safety;

Secondary

MeasureTime frame
Progression Free Survival;

Countries

China

Contacts

Public ContactLuo Jianmin

The Second Hospital of Hebei Medical University

luojm315@163.com+86 15803210952

Outcome results

None listed

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