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Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma (EECBL)

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CD19-targeted CAR-T cells

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma CAR-T

Eligibility Criteria

3 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed by pathological biopsy in patients with diffuse large B cell lymphoma by standard solution treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirmed the tumor cell surface expression positive intervention molecular targets, mainly for the CD19 (+) and/or CD20 (+).
Age 3 to 75 years old, both male and female;
Is expected to survive more than 3 months;
Physical condition is good: 0-2 score ECOG score;
In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
General requirements peripheral blood as basic, normal blood T lymphocytes in peripheral blood count must >= 0.2 x10^9 / L;
No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

The recurrent or refractory patients with diffuse large B cell lymphoma.
Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
Coagulation abnormalities and severe thrombosis;
Pregnancy and lactation women;
Any other chronic disease patients who have been treated with immune agents or hormone therapy;
Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
The Investigator believe the patients should not participate in this experiment.

Sites / Locations

The First Affiliated Hospital of Anhui Medical UniversityRecruiting

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:0 days，the first day,the fourth day,the seventh day,28 days,31 days,34 days. Duration:Total seven times.

Outcomes

Primary Outcome Measures

Objective Reaction Rates

Secondary Outcome Measures

Full Information

NCT ID

NCT02728882

First Posted

March 29, 2016

Last Updated

March 21, 2017

Sponsor

Sinobioway Cell Therapy Co., Ltd.

Collaborators

The First Affiliated Hospital of Anhui Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02728882

Brief Title

Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma

Acronym

EECBL

Official Title

Single Arm, Two Phase, Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2, 2015 (Actual)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinobioway Cell Therapy Co., Ltd.

Collaborators

The First Affiliated Hospital of Anhui Medical University

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 single-arm, multicenter Phase 2 study will treat the patients who have Recurrent or refractory diffuse large B cell 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 that express the EPCAM 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 with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

Detailed Description

This is a single-arm, multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Recurrent or refractory diffuse large B cell lymphoma.The study will be conducted using a phase I/II design. 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 is 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

Lymphoma CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

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)

CD19-targeted CAR-T cells

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

Objective Reaction Rates

Time Frame

0 to 180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed by pathological biopsy in patients with diffuse large B cell lymphoma by standard solution treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirmed the tumor cell surface expression positive intervention molecular targets, mainly for the CD19 (+) and/or CD20 (+). Age 3 to 75 years old, both male and female; Is expected to survive more than 3 months; Physical condition is good: 0-2 score ECOG score; In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination. General requirements peripheral blood as basic, normal blood T lymphocytes in peripheral blood count must >= 0.2 x10^9 / L; No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form. Exclusion Criteria: The recurrent or refractory patients with diffuse large B cell lymphoma. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution; Coagulation abnormalities and severe thrombosis; Pregnancy and lactation women; Any other chronic disease patients who have been treated with immune agents or hormone therapy; Patients who have participated in other clinical trials or other clinical trials in the past 30 days; The Investigator believe the patients should not participate in this experiment.

Central Contact Person:

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

Kangsheng Gu, PI

Phone

13805692145

13805692145@163.com

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

Yang Jiao, Investigator

Phone

13966699766

graveboy@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kangsheng Gu, PI

Organizational Affiliation

Chief physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Anhui Medical University

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230022

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plans to share data.

Citations:

PubMed Identifier

34515338

Citation

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Results Reference

derived

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Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma

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