Status:
UNKNOWN
Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborating Sponsors:
Gracell Biotechnologies (Shanghai) Co., Ltd.
First Affiliated Hospital of Zhejiang University
Conditions:
Relapsed Adult ALL
B Cell Leukemia
Eligibility:
All Genders
14-75 years
Phase:
PHASE1
Brief Summary
The patients with relapsed B cell acute lymphoblastic leukemia (ALL) after hematopoietic stem cell transplant (HSCT) have a poor prognosis, especially for these relapsed in a short time after transpla...
Detailed Description
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic...
Eligibility Criteria
Inclusion
- Diagnosis of relapsed B-cell acute lymphoblastic leukemia (B-ALL).
- Patients have received hematologic stem cell transplantation from matching sibling donor or unrelated donor.
- CD19-positive tumor (\>20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
- Hgb ≥ 7.0 (can be transfused)
- Life expectancy greater than 12 weeks
- Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Exclusion
- Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
- Severe mental disorders；
- A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
- Subjects with II-IV grade acute graft versus host disease GVHD (Glucksberg Standrad) or chronic GVHD.
- Heart disease with grade III-IV heart failure \[NYHA classification\], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission；
- Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed)；
- Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
- Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
- Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
- Active infection requiring systematic treatment within 2 weeks before single collection；
- Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
- History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years；
- Presence of pulmonary fibrosis；
- Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer)；
- Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up；
- At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment；
- The lactating woman who is reluctant to stop breastfeeding；
- Any other condition considered unsuitable by the investigator.
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04516551
Start Date
November 20 2020
End Date
December 1 2022
Last Update
November 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China, 400037