CART-19 Cells for R/R B-cell Lymphoma

NCT ID: NCT03391726

Last Updated: 2018-01-05

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

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-12-31

Brief Summary

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Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

Detailed Description

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Conditions

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Relapsed or Refractory 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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Arm 1

CART-19 cells treat

Group Type EXPERIMENTAL

CART-19 cells

Intervention Type OTHER

CART-19 cells treat

Interventions

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CART-19 cells

CART-19 cells treat

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Aged between 1-65 years
* Patients with relapse/refractory B-cell lymphoma
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.
Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianda Hu

Director of the department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianda Hu, Prof.M.D.Ph.D

Role: CONTACT

86-13959169016

Facility Contacts

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Jianda Hu, Prof.

Role: primary

86-13959169016

Ting Yang, Prof.

Role: backup

86-13950210357

Other Identifiers

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CART-19-01

Identifier Type: -

Identifier Source: org_study_id

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