Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
This single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or
 refractory diffuse large B cell lymphoma with an infusion of the patient's own T cells that
 have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to
 tumour cells that express the EPCAM protein on the cell surface.The study will determine if
 these modified T cells help the body's immune system eliminate tumour cells.The trial will
 also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body
 and the impact of this treatment on survival.
This is a single-arm, multicenter Phase 2 study to evaluate the efficacy and safety of the
 CAR-T for Recurrent or refractory diffuse large B cell lymphoma.The study will be conducted
 using a phase I/II design. The study will have the following sequential phases: Part A
 (screening leukapheresis,cell product preparation, and cytoreductive chemotherapy) and Part B
 (treatment and follow-up). The follow-up period for each participant is approximately 35
 months after the final CAR-T infusion. The total duration of the study is expected to be
 approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
Inclusion Criteria:

 1. Confirmed by pathological biopsy in patients with diffuse large B cell lymphoma by
 standard solution treatment is invalid or recurrence of refractory, and by flow
 cytometry or pathological immunohistochemical examination, confirmed the tumor cell
 surface expression positive intervention molecular targets, mainly for the CD19 (+)
 and/or CD20 (+).

 2. Age 3 to 75 years old, both male and female;

 3. Is expected to survive more than 3 months;

 4. Physical condition is good: 0-2 score ECOG score;

 5. In group of four weeks before Canon imaging examination evaluation body tumor load,
 recommend line PET - CT examination.

 6. General requirements peripheral blood as basic, normal blood T lymphocytes in
 peripheral blood count must >= 0.2 x10^9 / L;

 7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the
 body;

 8. Into groups to participate in voluntarily, good adherence, can cooperate test
 observation, childbearing age women must be 7 days before starting treatment expert
 pregnancy test and the results were negative, and signed a written informed consent
 form.

 Exclusion Criteria:

 1. The recurrent or refractory patients with diffuse large B cell lymphoma.

 2. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver
 function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe
 respiratory failure; brain: disorder of consciousness;

 3. Existing serious acute infection, uncontrollable, or have fester sex and chronic
 infection, wound in delay no more;

 4. Patients with significant graft versus host disease (GVHD) after organ transplant
 history or allogeneic hematopoietic stem cell transplantation;

 5. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic
 constitution;

 6. Coagulation abnormalities and severe thrombosis;

 7. Pregnancy and lactation women;

 8. Any other chronic disease patients who have been treated with immune agents or hormone
 therapy;

 9. Patients who have participated in other clinical trials or other clinical trials in
 the past 30 days;

 10. The Investigator believe the patients should not participate in this experiment.