Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Conditions
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B Cell Lymphoma

Intervention / Treatment
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* Combination Product: CAR-T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR-T treatment<br>In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated | Combination Product: CAR-T<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | complete remission rate after treated by CAR-T therapy | every 3 months until 20 months after the last patient's enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment | 
| overall survival | from the date of inclusion to date of death, irrespective of cause | 20 months after the last patient's enrollment | 
| adverse events | 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 | from the date of the start of treatment to 20 months after last patient's enrollment | 
| duration of the modified T cells by CAR-T in the patients | time from re-transfusion to date when the modified T cells become non-detectable. | from the date of re-transfusison to 20 months after last patient's enrollment |