Status:
UNKNOWN
Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Anti...
Eligibility Criteria
Inclusion
- Age≥18 years, male or female;
- Karnofsky≥60%；
- 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).
- Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
- Patients have had more than 2 combined chemotherapy regimens;
- Creatinin \<2.5mg/dL；ALT/AST level \<3 times of the maximum of normal range; bilirubin\<3mg/dL；
- Proper venous condition for leukapheresis, no contraindication for leukapheresis;
- Patient that could understand and is willing to sign the written consent;
- Fertile female patient should be willing to take contraceptive measures.
- Patient that is willing to follow up till at least 2 months after T cell re-transfusion.
Exclusion
- Patients who need ≥15mg prednisone daily due to any cause;
- Patients with autoimmune disease and need immunosuppressor treatment;
- Serum creatinin\>2.5 mg/dL；serum AST \>5 times of normal maximum; bilirubin \>3 mg/Dl;
- FEV1\<2 L，diffusion capacity for carbon monoxide of lung (DLCO) \<40%；
- 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%；
- Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
- Patients that have previously received gene therapy of any kind;
- Obvious clinical encephalopathy or novel neuron function damage;
- Patients with active infection;
- Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
- Patients who had allergic history to agents of the similar structure as CAR-T;
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03258047
Start Date
September 15 2017
End Date
July 30 2019
Last Update
February 15 2019
Active Locations (1)
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1
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000