B Cell Lymphoma
Conditions
Brief summary
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients. Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
Interventions
COMBINATION_PRODUCTCAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years, male or female; 2. Karnofsky≥60%； 3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years). 4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons. 5. Patients have had more than 2 combined chemotherapy regimens; 6. Creatinin \<2.5mg/dL；ALT/AST level \<3 times of the maximum of normal range; bilirubin\<3mg/dL； 7. Proper venous condition for leukapheresis, no contraindication for leukapheresis; 8. Patient that could understand and is willing to sign the written consent; 9. Fertile female patient should be willing to take contraceptive measures. 10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.
Exclusion criteria
1. Patients who need ≥15mg prednisone daily due to any cause; 2. Patients with autoimmune disease and need immunosuppressor treatment; 3. Serum creatinin\>2.5 mg/dL；serum AST \>5 times of normal maximum; bilirubin \>3 mg/Dl; 4. FEV1\<2 L，diffusion capacity for carbon monoxide of lung (DLCO) \<40%； 5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction\<35%； 6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection; 7. Patients that have previously received gene therapy of any kind; 8. Obvious clinical encephalopathy or novel neuron function damage; 9. Patients with active infection; 10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment; 11. Patients who had allergic history to agents of the similar structure as CAR-T;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | every 3 months until 20 months after the last patient's enrollment | complete remission rate after treated by CAR-T therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment | from date of inclusion to date of progression, relapse, or death from any cause |
| overall survival | 20 months after the last patient's enrollment | from the date of inclusion to date of death, irrespective of cause |
| adverse events | from the date of the start of treatment to 20 months after last patient's enrollment | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure |
| duration of the modified T cells by CAR-T in the patients | from the date of re-transfusison to 20 months after last patient's enrollment | time from re-transfusion to date when the modified T cells become non-detectable. |
Countries
China
Outcome results
None listed