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

NCT ID: NCT03086954

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2021-03-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

Interventions

The 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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: collaborator

Sinobioway Cell Therapy Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jifeng Feng, Professor

Role: PRINCIPAL_INVESTIGATOR

Director of medical oncology

Locations

Jiangsu Cancer hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Jifeng Feng, Professor

Role: CONTACT

fjif@vip.sina.com

13901581264

Facility Contacts

Jifeng Feng, Professor

Role: primary

fjif@vip.sina.com

13901581264

References

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.

Reference Type: BACKGROUND

PMID: 27605551 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/27605551

Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells.

Other Identifiers

WM-CART-02

Identifier Type: -

Identifier Source: org_study_id