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CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

NCT ID: NCT03263208

Last Updated: 2017-10-20

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2019-07-31

Brief Summary

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The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.

Detailed Description

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Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T.

Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.

Conditions

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B-cell Acute Lymphocytic Leukemia

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

A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).

Fludarabine

Intervention Type DRUG

Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).

CD19 CAR-T

Intervention Type BIOLOGICAL

CD19 CAR-T cells will be administered after completion of the chemotherapy.

Interventions

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Cyclophosphamide

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).

Intervention Type DRUG

Fludarabine

Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).

Intervention Type DRUG

CD19 CAR-T

CD19 CAR-T cells will be administered after completion of the chemotherapy.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 1\. 2 years to 70 years, expected survival \> 3 months;
* 2\. CD19 positive B-cell acute lymphoblastic leukemia;
* 3\. ECOG \< 2；
* 4\. The tumor load in the bone marrow is less than 60%;
* 5\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
* 6\. No leukemia cells in the central nervous system;
* 7\. No serious allergic constitution;
* 8\. No other serous diseases that conflicts with the clinical program;
* 9\. No other cancer history;
* 10\. No serious mental disorder;
* 11\. female participants of reproductive potential must have a negative serum pregnancy test;
* 12\. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

* 1\. Pregnant or lactating women;
* 2\. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* 3\. Active hepatitis B or hepatitis C infection;
* 4\. Recent or current use of glucocorticoid or other immunosuppressor;
* 5\. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* 6\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Pregene (ShenZhen) Biotechnology Company, Ltd.

INDUSTRY

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongping Song

Role: CONTACT

Phone: +86 13521186987

Email: [email protected]

Facility Contacts

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Haiping Yang

Role: primary

Yongping Song

Role: primary

Other Identifiers

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HenanCH152

Identifier Type: -

Identifier Source: org_study_id