CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell... | NCT03881761

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

NCT03881761

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2019Actual

Enrollment

50Estimated

Phase

Phase 1

Conditions

B-Cell Lymphoma Stage I
Refractory
Relapsed

Interventions

CD19/CD20 bispecific CAR-T cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Jan 31, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Mar 16, 2019

First Submission Date that Met QC Criteria

Mar 16, 2019

First Posted Date

Mar 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2019

Last Update Posted Date

Mar 21, 2019Actual

Name	Class
Henan Hualong Biotechnology Company	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental arm	Experimental	CAR-T cell group	Biological: CD19/CD20 bispecific CAR-T cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD19/CD20 bispecific CAR-T cells	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
occurrence of study related adverse events	safety of CAR-T cells	one year

Secondary Outcomes

Measure	Description	Time Frame
objective response rate	proportion of patients with complete response and partial response	three months
survival time of CAR-T cells in vivo	from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yongping Song, Dr.	Contact	+86-37165587795		songyongping2018@126.com
Quanli Gao, Dr.	Contact	+86-37165587483		gaoquanli2015@126.com

Overall Officials

Name	Affiliation	Role
Yongping Song, Dr.	Henan Cancer Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital	Recruiting	Zhengzhou	Henan	450000	China

Condition Browse Module

MeSH Terms

ID	Term
D016393	Lymphoma, B-Cell
D012008	Recurrence

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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Browse Branches

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