Lymphoma
Conditions
Keywords
CD19 positive lymphoma
Brief summary
This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive 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 modified to express the CD19 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 for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
Detailed description
This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign 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 are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
Interventions
BIOLOGICALThe Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
Sponsors
Jiangsu Cancer Institute & Hospital
Sinobioway Cell Therapy Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Age older than 16 years old,gender and race no limited. * 2.Pathological diagnosis of CD19 express positive recurrent or refractory B lymphoma, satisfy any of the following a diagnosis of recurrent or refractory lymphoma: (1) According to the standard solution standardization more than four courses of treatment, tumor size \< 50% or progression;(2) According to the standard solution treatment of complete remission, after recurrence again with the original plan or the national expert consensus recommended second-line cannot again get to complete remission (3) Relapse after hematopoietic stem cell transplantation. * 3.Patients into the group needs lesions to be available for testing or evaluating disease. * 4.ECOG score reaches 0 to 1 points. * 5.Patients into the group of White Blood Cell counts in peripheral blood acuity≥ 1.0 x10\^9 / L. * 6.Estimated survival times \> 90 days. * 7.Patients have self-knowledge ability, can sign the informed consent form.
Exclusion criteria
* 1.Pregnant or lactating women. * 2.Uncontrolled infection. * 3.HIV infection, hepatitis B or C activity period. * 4.Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.) * 5.Combined activity of the central nervous system malignant tumor invasion. * 6.Abnormal coagulation function, patients with severe thrombosis. * 7\. Organ failure Heart：class Ⅱ or above. Liver：class Ⅱ or above( Refer to Classification of Wuhan Conference (1983)). Kidney: The second stage of renal insufficiency or above. Lung: class Ⅱdecreased slightly or above. Brain: The central nervous system transfer or have active lesions. * 8.Patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time. * 9.Investigator believe that the patient is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy. | up to 90 days | The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3°or above incidence rate of serious adverse reaction related to treatment | 3years | According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction. |
| Patients - -based Quality of Life Evaluation | 3years | According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality. |
| Progression free survival time | 3years | From patients into the group to the interval between disease progression or death. |
| Overall survival time | 3years | From all patients into the group to the interval between death caused by any reason . |
Countries
China
Contacts
Primary ContactJifeng Feng, Professor
Outcome results
None listed