CART-19 T Cell in CD19 Positive Relapsed or Refractory Ac... | NCT03896854

Studies
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT03896854

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Status

Unknown status

Last Update Posted

Nov 29, 2023Actual

Enrollment

15Estimated

Phase

Phase 1Phase 2

Conditions

Acute Myeloid Leukemia

Interventions

CART-19

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

Nov 2023

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

Oct 18, 2017Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 25, 2019

First Submission Date that Met QC Criteria

Mar 28, 2019

First Posted Date

Apr 1, 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

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

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

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Detailed Description

The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD19 positive relapsed or refractory acute myeloid leukemia	Experimental	MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia	Biological: CART-19

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CART-19	Biological	CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).	CD19 positive relapsed or refractory acute myeloid leukemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Adverse events are evaluated with CTCAE V4.03	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia
Age 6-65 years.
Left ventricular ejection fractions≥ 0.5 by echocardiography.
Creatinine < 1.6 mg/dL.
Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
Bilirubin <2.0 mg/dL.
Karnofsky performance status ≥ 60
Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

Pregnant or lactating women.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
HIV infection.
Patients with history of seizure
Active central nervous system leukemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaowen Tang, Ph.D.	Contact	(0086)51267781856		tangxiaowen@suda.edu.cn
Lei Yu, Ph.D.	Contact	(0086)13818629089		ylyh188@163.com

Overall Officials

Name	Affiliation	Role
Xiaowen Tang, Ph.D.	The First Affiliated Hospital of Soochow University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Soochow University	Recruiting	Suzhou	Jiangsu	215000	China

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000598123	CTL019 chimeric antigen receptor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided