The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
With
Xinqiao Hospital of Chongqing
Xuzhou Medical University
Primary objectives
1\. To determine the safety and feasibility of adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma
Secondary objectives
1. To measure the efficacy of anti-tumor responses after CD19CAR T cell infusion
2. To determine if CD19CAR T cells engineered with 4-1BB signaling domain is superior to that with CD28 signaling domain for their homing and persistence after CD19CAR T cell infusion
Age
5–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 5 Years to 70 Years, Male and female;
2. Expected survival \> 12 weeks;
3. Performance score 0-2;
4. Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions;
You may not be if
* Disease recurrence after stem cell transplantation;
* Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
5. Creatinine \< 2.5 mg/dl;
6. ALT/AST \< 3x normal;
7. Bilirubin \< 2.0 mg/dl;
8. Adequate venous access for apheresis, and no other contraindications for leukapheresis;
9. Take contraceptive measures before recruit to this trial;
10. Written voluntary informed consent is given.
1. Patients with symptoms of central nervous system
2. Accompanied by other malignant tumor
3. Active hepatitis B or C, HIV infection
4. Any other diseases could affect the outcome of this trial
5. Suffering severe cardiovascular or respiratory disease
6. Poorly controlled hypertension
7. A history of mental illness and poorly controlled
8. Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
9. Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
10. Reaching a steady dose if receiving anticoagulant therapy before assignment
11. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
12. Pregnant or lactating women
13. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Clareo Health | Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma
