Relapsed or Refractory B-cell Lymphomas Clinical Trial
Official title:
The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | April 3, 2020 |
| Est. primary completion date | April 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1.Patients diagnosed with B-cell relapse/refractory lymphoma have no effective treatment option. They have been treated for more than 2 years after autologous or allogeneic stem cell transplantation. 2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is =50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula = 40 ml/min. ALT value and AST value = 3 times normal range. Total bilirubin =2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%. 5. Blood routine parameters: Hgb=80g/L, ANC=1×109/L, PLT=50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications. 9.ECOG??=2. 10. Patients need to sign informed consent. Exclusion Criteria: 1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months; 2. Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.); 3. The patient is an active hepatitis B or hepatitis C infection. 4. The patient received genetic product treatment within six months. 5. The patient participated in a clinical trial within six months. 6. The patient has a severe autoimmune disease. 7. The doctor thinks that there are other reasons that can't be accepted. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| Xin Wang |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Study related adverse events [ Time Frame: 4 weeks ] | Occurrence of study related adverse events, defined as NCI CTC = Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible. | 4 weeks | |
| Secondary | Graft Activity Endpoint Detection | The PCR method was used to detect the copy number of the exogenous CAR vector in the blood until the end of the test was negative for both tests. | 24 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 quarter, 2 quarters, 3 months after returning to CART cells. Data were collected in quarters, 4 quarters, 5 quarters, 6 quart |