Clinical trial NCT02729493: Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer
Official title: Single Arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Keywords: Liver Cancer CAR-T
Lead sponsor: Sinobioway Cell Therapy Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 25
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or refractory liver cancer 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 Liver Cancer.The study will be conducted using a phaseⅠ /Ⅱ disign.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 paticipant 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 25 patients may be enrolled over a period of 3 years.

Eligibility criteria: Inclusion Criteria:

1. According to UICC or liver cancer diagnosis and treatment guideline of diagnosis for hepatocellular carcinoma in patients with, the traditional treatment of invalid, advanced liver cancer, or postoperative relapse or refractory patients with hepatocellular carcinoma, and through flow cytometry or immune tissues (cell) chemistry, confirmation of tumor cells positive expression of relevant molecular targets;
2. Age \<=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. The lymphocyte count must \> =0.4\*10\^9/L at the time of collection of peripheral blood;
6. Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;
7. Non pregnancy and lactation;
8. History of severe allergic reactions without biological products;
9. Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;
10. At least one measurable lesion.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Organ failure, such as heart: Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
4. Long term use of immunosuppressive drugs or people with severe autoimmune diseases;
5. Any other chronic disease patients who have been treated with immune agents or hormone therapy;
6. A serious infectious disease with severe, uncontrollable, wound healing
7. Allergy to the interleukin and interferon cytokine;
8. Coagulation abnormalities and severe thrombosis;
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.

Primary outcomes:
measure: Disease control rates
timeFrame: CAR - T back to lose 0 days to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui No.2 Province People's Hospital
state: Anhui
Study officials:
affiliation: associate chief physician
name: Xianping Cheng, PI
role: PRINCIPAL_INVESTIGATOR
References: