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

NCT03086954 | Unknown Phase 1

• 1 other identifier: WM-CART-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

CD19 positive lymphoma

Outcome Measures

Primary Outcomes (1)

• The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.

  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.

  up to 90 days

Secondary Outcomes (4)

• Progression free survival time

  3years

• Overall survival time

  3years

• Patients - -based Quality of Life Evaluation

  3years

• 3°or above incidence rate of serious adverse reaction related to treatment

  3years

Study Arms (1)

single arm

EXPERIMENTAL

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

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

Interventions

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

single arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 16 years old,gender and race no limited.
• 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.
• Patients into the group needs lesions to be available for testing or evaluating disease.
• ECOG score reaches 0 to 1 points.
• Patients into the group of White Blood Cell counts in peripheral blood acuity≥ 1.0 x10\^9 / L.
• Estimated survival times \> 90 days.
• Patients have self-knowledge ability, can sign the informed consent form.

You may not qualify if:

• Pregnant or lactating women.
• Uncontrolled infection.
• HIV infection, hepatitis B or C activity period.
• Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.)
• Combined activity of the central nervous system malignant tumor invasion.
• Abnormal coagulation function, patients with severe thrombosis.
• \. 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.
• Patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time.
• Investigator believe that the patient is not suitable to participate in the study.

Sponsors & Collaborators

• Sinobioway Cell Therapy Co., Ltd.: lead
• Jiangsu Cancer Institute & Hospital: collaborator

Study Sites (1)

Jiangsu Cancer hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• 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.

  PMID: 27605551 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jifeng Feng, Professor

  Director of medical oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jifeng Feng, Professor

CONTACT

13901581264; fjif@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)