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

Primary Purpose

NHL

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IM19 CAR-T Cells

About this trial

This is an interventional treatment trial for NHL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IM19 CAR-T cells

Arm Description

IM19 CAR-T cells be administrated in two dose level

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR) at 90 days

The primary endpoint was ORR 90 days after IM19 infusion

Secondary Outcome Measures

Full Information

NCT ID

NCT04440436

First Posted

June 18, 2020

Last Updated

December 4, 2020

Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04440436

Brief Title

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

Official Title

Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Recruiting

Study Start Date

June 4, 2020 (Actual)

Primary Completion Date

June 4, 2022 (Anticipated)

Study Completion Date

June 4, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NHL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IM19 CAR-T cells

Arm Type

Experimental

Arm Description

IM19 CAR-T cells be administrated in two dose level

Intervention Type

Drug

Intervention Name(s)

IM19 CAR-T Cells

Other Intervention Name(s)

Fludarabine, Cyclophosphamide

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate(ORR) at 90 days

Description

The primary endpoint was ORR 90 days after IM19 infusion

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Wu, MD

Phone

+8615801390058

wufei@immunochina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuqin Song, MD, PhD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuqin Song, MD, PhD

Phone

+8618911576946

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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