Clinical trial NCT03086954: Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma
Official title: Open, Single Arm,Multicenter Phase 2 Clinical Study to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for CD19 Positive Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lymphoma
Keywords: CD19 positive lymphoma
Lead sponsor: Sinobioway Cell Therapy Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Cancer Institute & Hospital
First posted: 2017-03-22
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.
timeFrame: up to 90 days
Secondary outcomes:
measure: Progression free survival time
timeFrame: 3years
measure: Overall survival time
timeFrame: 3years
measure: Patients - -based Quality of Life Evaluation
timeFrame: 3years
measure: 3°or above incidence rate of serious adverse reaction related to treatment
timeFrame: 3years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer hospital
state: Jiangsu
Study officials:
affiliation: Director of medical oncology
name: Jifeng Feng, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turtle CJ, Hanafi LA, Berger C, Hudecek M, Pender B, Robinson E, Hawkins R, Chaney C, Cherian S, Chen X, Soma L, Wood B, Li D, Heimfeld S, Riddell SR, Maloney DG. Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med. 2016 Sep 7;8(355):355ra116. doi: 10.1126/scitranslmed.aaf8621.