CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

NCT ID: NCT03881761

Last Updated: 2019-03-21

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

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-01-31

Brief Summary

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Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Detailed Description

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CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Conditions

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B-Cell Lymphoma Stage I Refractory Relapsed

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental arm

CAR-T cell group

Group Type EXPERIMENTAL

CD19/CD20 bispecific CAR-T cells

Intervention Type BIOLOGICAL

collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg

Interventions

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CD19/CD20 bispecific CAR-T cells

collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* expected lifetime\>3 months
* CD19/CD20 positive relapsed/refractory B cell lymphoma
* KPS\>70
* at least one measurable lesion according to RECIST 1.1
* enough function of hear, liver, kidney and bone marrow
* no history of severe allergies
* no other history of malignancy
* no other diseases that conflict with this regimen
* no serious mental illness
* patient or family member sign informed consent

Exclusion Criteria

* Pregnant or lactating women
* Severe infectious or viral disease
* Active B or C viral hepatitis
* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
* participated in other clinical studies in the last 3 months, or have been treated with other gene products
* Others not appropriate to participate in this study examined by the investigators
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Hualong Biotechnology Company

UNKNOWN

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongping Song, Dr.

Role: STUDY_CHAIR

Henan Cancer Hospital

Locations

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Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongping Song, Dr.

Role: CONTACT

+86-37165587795

Quanli Gao, Dr.

Role: CONTACT

+86-37165587483

Facility Contacts

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Yongping Song, Dr.

Role: primary

+86-37165587795

Quanli Gao, M.D

Role: primary

+86-15038171966

Lu Han, M.D

Role: backup

+86-13838583031

Other Identifiers

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HenanCH CART 2-3

Identifier Type: -

Identifier Source: org_study_id

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