Single Arm, Two Phase, Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphoma
- Sponsor
- Sinobioway Cell Therapy Co., Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Objective Reaction Rates
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 (+).
- •Age 3 to 75 years old, both male and female;
- •Is expected to survive more than 3 months;
- •Physical condition is good: 0-2 score ECOG score;
- •In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
- •General requirements peripheral blood as basic, normal blood T lymphocytes in peripheral blood count must \>= 0.2 x10\^9 / L;
- •No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
- •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
- •The recurrent or refractory patients with diffuse large B cell lymphoma.
- •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;
- •Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- •Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- •Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
- •Coagulation abnormalities and severe thrombosis;
- •Pregnancy and lactation women;
- •Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- •Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
- •The Investigator believe the patients should not participate in this experiment.
Outcomes
Primary Outcomes
Objective Reaction Rates
Time Frame: 0 to 180 days