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

Sponsored by Hebei Senlang Biotechnology Inc., Ltd.

About this trial

Last updated 5 years ago

Study ID

CAR-T for adult B-ALL

Status

Unknown status

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

18-75 Years
14 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

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

2. ECOG score≤2;

3. To be aged 1 to 65 years;

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

No

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.

Locations

Location

Status

Recruiting