Status:
UNKNOWN
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
Lead Sponsor:
Liqun Zou
Conditions:
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relaps...
Eligibility Criteria
Inclusion
- Male or female aged 18-70 years;
- Estimated survival time ≥ 12 weeks;
- Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
- Ineffectively or relapses after 2 or more remedial treatments
- Relapse after auto-HSCT or unsuitable for auto-HSCT;
- At least one assessable tumor lesion;
- ECOG performance status 0 to 2;
- Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
- Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion
- Patients with other uncontrolled malignancies;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
- Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
- Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
- Patients with atrial or ventricular involvement by B-cell malignancies;
- Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
- Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;
- Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;
- Any situations that the investigators believes were not suitable for this trial;
- Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
- Pregnant(or lactation) women;
- Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04684472
Start Date
March 17 2021
End Date
January 1 2024
Last Update
September 26 2022
Active Locations (1)
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1
Sichuan University
Chengdu, Sichuan, China