Overview

Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

Status:
Recruiting
Trial end date:
2023-05-30
Target enrollment:
0
Participant gender:
All
Summary
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Treatments:
Cyclophosphamide
Fludarabine
Criteria
Inclusion Criteria:

1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid
Malignancies:

2. ECOG scoreā‰¤2;

3. To be aged 1 to 65 years;

4. More than a month lifetime from the consent signing date.

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;

2. Has a history of severe pulmonary function damaging;

3. Merging other progressing malignant tumor;

4. Merging uncontrolled infection;

5. Merging the metabolic diseases (except 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. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after
stopping immunosuppressants a month;

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.