Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma (EECPL)

Sinobioway Cell Therapy

Status and phase: Unknown; Phase 1

Conditions: Lymphoma

Treatments: Biological: The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03086954

WM-CART-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

single arm

Experimental group

Description:

Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times

Treatment:

Biological: The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)