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

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring CD19 positive lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jiangsu Cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression free survival time

From patients into the group to the interval between disease progression or death.

Overall survival time

From all patients into the group to the interval between death caused by any reason .

Patients - -based Quality of Life Evaluation

According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality.

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

According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction.

Full Information

NCT ID

NCT03086954

First Posted

March 13, 2017

Last Updated

March 21, 2017

Sponsor

Sinobioway Cell Therapy Co., Ltd.

Collaborators

Jiangsu Cancer Institute & Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03086954

Brief Title

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

Acronym

EECPL

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2017 (Anticipated)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinobioway Cell Therapy Co., Ltd.

Collaborators

Jiangsu Cancer Institute & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

CD19 positive lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to 90 days

Secondary Outcome Measure Information:

Title

Progression free survival time

Description

From patients into the group to the interval between disease progression or death.

Time Frame

3years

Title

Overall survival time

Description

From all patients into the group to the interval between death caused by any reason .

Time Frame

3years

Title

Patients - -based Quality of Life Evaluation

Description

According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality.

Time Frame

3years

Title

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

Description

According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction.

Time Frame

3years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jifeng Feng, Professor

Phone

13901581264

fjif@vip.sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jifeng Feng, Professor

Organizational Affiliation

Director of medical oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiangsu Cancer hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jifeng Feng, Professor

Phone

13901581264

fjif@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27605551

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.

Results Reference

background

Links:

URL

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

Description

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

Learn more about this trial

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

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