Assessment of Safety and Efficacy of IM19 for Recurrent o... | NCT04440436

Studies
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

NCT04440436

Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Status

Recruiting

Last Update Posted

Dec 8, 2020Actual

Enrollment

52Estimated

Phase

Phase 1Phase 2

Conditions

Interventions

IM19 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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2020Actual

Primary Completion Date

Jun 4, 2022Estimated

Completion Date

Jun 4, 2035Estimated

First Submitted Date

Jun 18, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 19, 2020Actual

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

Dec 4, 2020

Last Update Posted Date

Dec 8, 2020Actual

Name	Class
Jiangsu Simcere Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Detailed Description

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's 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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IM19 CAR-T cells	Experimental	IM19 CAR-T cells be administrated in two dose level	Drug: IM19 CAR-T Cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IM19 CAR-T Cells	Drug	IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Measure	Description	Time Frame
Objective Response Rate(ORR) at 90 days	The primary endpoint was ORR 90 days after IM19 infusion	90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
CD20 positive patients undergo corresponding targeted therapy.
Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
≥ 18 years old.
The expected survival period is more than 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up
Participate voluntarily in this experiment and sign the informed consent.

Exclusion Criteria:

The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
Subject has used any gene therapy products before.
Subject with a history of epilepsy or other central nervous system diseases.
Active Hepatitis B Virus or Hepatitis C Virus infections
The subject with other tumors in the past 5 years.
Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated