Adult B Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility | 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. 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. |
Country | Name | City | State |
---|---|---|---|
China | No.2 Hospital of Hebei Medical University | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Hebei Senlang Biotechnology Inc., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Severe/Adverse Events as a Measure of Safety | Number of Participants with Severe/Adverse Events as a Measure of Safety | 28 days | |
Primary | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | 24 months | |
Secondary | Objective response rate of complete remission and partial remission | Objective response rate of complete remission and partial remission | 24 months | |
Secondary | Overall survival time | Overall survival time | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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