Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT
NCT ID: NCT04516551
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2020-11-20
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-CD19 allo-CAR-T
The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage.
dosage: the number of anti CD19+CD22 CAR T cells
-1(if needed) 1×10\^6/KG
3×10\^6 /KG 6×10\^6 /KG 1×10\^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion.
anti-CD19 allo-CAR-T cells
The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
Interventions
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anti-CD19 allo-CAR-T cells
The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
Eligibility Criteria
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Inclusion Criteria
2. Patients have received hematologic stem cell transplantation from matching sibling donor or unrelated donor.
3. CD19-positive tumor (\>20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
4. Hgb ≥ 7.0 (can be transfused)
5. Life expectancy greater than 12 weeks
6. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Exclusion Criteria
2. Severe mental disorders；
3. A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
4. Subjects with II-IV grade acute graft versus host disease GVHD (Glucksberg Standrad) or chronic GVHD.
5. 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；
6. 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)；
7. Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
8. Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
9. Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
10. Active infection requiring systematic treatment within 2 weeks before single collection；
11. Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
12. 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；
13. Presence of pulmonary fibrosis；
14. 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)；
15. 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；
16. 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；
17. The lactating woman who is reluctant to stop breastfeeding；
18. Any other condition considered unsuitable by the investigator.
14 Years
75 Years
ALL
No
Sponsors
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Gracell Biotechnologies (Shanghai) Co., Ltd.
INDUSTRY
First Affiliated Hospital of Zhejiang University
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
The General Hospital of Western Theater Command
OTHER
Chongqing University Cancer Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Tang-Du Hospital
OTHER
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
OTHER
Xinqiao Hospital of Chongqing
OTHER
Responsible Party
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Xi Zhang, MD
Chef of Hematology Department
Principal Investigators
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Xi Zhang, MD phD
Role: STUDY_CHAIR
Xinqiao Hospital of Chongqing
He Huang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ruihao Huang
Role: primary
References
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Luo Y, Gao L, Liu J, Yang L, Wang L, Lai X, Gao S, Liu L, Zhao L, Ye Y, Wang M, Shen L, Cao WW, Wang D, Li W, Zhang X, Huang H. Donor-derived Anti-CD19 CAR T cells GC007g for relapsed or refractory B-cell acute lymphoblastic leukemia after allogeneic HSCT: a phase 1 trial. EClinicalMedicine. 2023 Dec 21;67:102377. doi: 10.1016/j.eclinm.2023.102377. eCollection 2024 Jan.
Other Identifiers
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Anti-CD19 allo-CAR-T
Identifier Type: -
Identifier Source: org_study_id