Adult B Acute Lymphoblastic Leukemia
Conditions
Brief 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.
Detailed description
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。
Interventions
DRUGCD19 CAR-T
CD19 CAR-T infusion for patients with CD19 positive tumor cells
DRUGCD22 CAR-T
CD22 CAR-T infusion for patients with CD22 positive tumor cells
DRUGCD19+CD22 CAR-T
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
DRUGFludarabine
25mg/㎡ for D-4、D-3 and D-2
DRUGCyclophosphamide
500mg/㎡ for D-3 and D-2
Sponsors
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Severe/Adverse Events as a Measure of Safety | 28 days | Number of Participants with Severe/Adverse Events as a Measure of Safety |
| Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | 24 months | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate of complete remission and partial remission | 24 months | Objective response rate of complete remission and partial remission |
| Overall survival time | 24 months | Overall survival time |
Countries
China
Contacts
Primary ContactJianqiang Li, PhD&MD
Outcome results
None listed