Status:
UNKNOWN
CAR-T Cellular Therapy for B Cell Malignancies Involved in CNS
Lead Sponsor:
Zhejiang University
Conditions:
Hematological Malignancy
Eligibility:
All Genders
3-75 years
Brief Summary
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary obje...
Detailed Description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled....
Eligibility Criteria
Inclusion
- Male or female aged ≥ 3 and \<70 years old; 2.Histologically confirmed diagnosis of CD19+ B cell malignancies involved in CNS 3.Relapsed or refractory CD19+ B cell malignancies 4.total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; 5.Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 6.No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%; 7.Estimated survival time ≥ 3 months; 8.ECOG performance status 0 to 2; 8.Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion
- Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
- extensive involvement of gastrointestinal lymphoma;
- radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
- Have a history of allergy to any of the components in the cell products;
- According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
- Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
- Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
- Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;
- History of other primary cancer, except for the following conditions:
- Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
- Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
- Patients with graft-versus-host disease (GVHD);
- Prior immunizations with live vaccine 4 weeks prior to screening; 13.History of alcoholism, drug abuse or mental illness; 14.Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids; 15.Patients who have participated in any other clinical studies within 2 weeks prior to screening; 16.pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender); 17.Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
February 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04287309
Start Date
February 28 2020
End Date
February 28 2023
Last Update
February 27 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310000
2
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003