Clinical trial NCT03258047: Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Official title: Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: B Cell Lymphoma
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: complete remission rate
timeFrame: every 3 months until 20 months after the last patient's enrollment
Secondary outcomes:
measure: progression free survival
timeFrame: from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment
measure: overall survival
timeFrame: 20 months after the last patient's enrollment
measure: adverse events
timeFrame: from the date of the start of treatment to 20 months after last patient's enrollment
measure: duration of the modified T cells by CAR-T in the patients
timeFrame: from the date of re-transfusison to 20 months after last patient's enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: