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CAR T Cells for Refractory B Cell Malignancy

NCT ID: NCT02963038

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-30

Brief Summary

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Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

Detailed Description

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The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Conditions

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B-Cell Leukemia B-Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CD19 CAR T cells

Autologous CD19-targeting CAR T cells

Group Type EXPERIMENTAL

Autologous CD19-targeting CAR T cells

Intervention Type BIOLOGICAL

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Interventions

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Autologous CD19-targeting CAR T cells

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. The treat history meeting the following criteria:

* Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
* Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
* One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG scoreā‰¤2;
4. To be aged 1 to 70 years;
5. More than a month lifetime from the consent signing date

Exclusion Criteria

* Serious cardiac insufficiency, left ventricular ejection fraction\<50;
* Has a history of severe pulmonary function damaging;
* Merging other malignant tumor;
* Merging uncontrolled infection;
* Merging the metabolic diseases (except diabetes);
* Merging severe autoimmune diseases or immunodeficiency disease;
* patients with active hepatitis B or hepatitis C;
* patients with HIV infection;
* Has a history of serious allergies on Biological products (including antibiotics);
* Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianmin Luo, PhD & MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Locations

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No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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jianqiang li, PhD & MD

Role: CONTACT

Phone: +8631189928689

Email: [email protected]

Jianmin Luo, PhD & MD

Role: CONTACT

Phone: +8631166002304

Facility Contacts

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Jianqiang Li, PhD & MD

Role: primary

Jianmin Luo, PhD & MD

Role: backup

Other Identifiers

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SenL_19

Identifier Type: -

Identifier Source: org_study_id