Back to results

Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

Primary Purpose

Non Hodgkin Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IM19

Fludarabine

Cyclophosphamide

About this trial

This is an interventional treatment trial for Non Hodgkin Lymphoma focused on measuring CAR-T

Eligibility Criteria

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

Inclusion criteria:

Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
Patients must have evaluable disease evidence;
Age ≥ 18 years old;
The expected life span is more than 3 months;
ECOG score 0-2 points (see Attachment 2);
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;
Those who voluntarily participate in the trial and sign the informed consent.

Exclusion criteria:

Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
Use chemotherapy or radiotherapy within 3 days before the blood collection period;
Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
Those who have previously used any gene therapy products;
History of epilepsy or other diseases of the central nervous system;
New York Heart Association (NYHA) class III or above (see Annex 3);
creatinine> 1.5 times the upper limit of normal or ALT / AST> 3 times the upper limit of normal or bilirubin> 2 times the normal upper limit;
active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
pregnant or lactating women;
suffer from other uncontrolled diseases that the researcher considers inappropriate;
Any condition that the investigator believes may increase the subject's risk or interfere with the test results.

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IM19 CAR-T cells

Arm Description

3*10^5/kg，1*10^6/kg，3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days

Outcomes

Primary Outcome Measures

Occurrence of study related adverse events

>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Secondary Outcome Measures

Overall response rate

(1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)

Full Information

NCT ID

NCT03528421

First Posted

May 7, 2018

Last Updated

July 13, 2018

Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Collaborators

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03528421

Brief Title

Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

Official Title

Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 22, 2018 (Actual)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Collaborators

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.

Detailed Description

Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

6. Conditions and Keywords

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

Non Hodgkin Lymphoma

Keywords

CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IM19 CAR-T cells

Arm Type

Experimental

Arm Description

3*10^5/kg，1*10^6/kg，3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days

Intervention Type

Biological

Intervention Name(s)

IM19

Intervention Description

CAR-T cells

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Two days before cell infusion, all patients will be treated with fludarabine for 3 days

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Primary Outcome Measure Information:

Title

Occurrence of study related adverse events

Description

>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall response rate

Description

(1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment. Patients must have evaluable disease evidence; Age ≥ 18 years old; The expected life span is more than 3 months; ECOG score 0-2 points (see Attachment 2); 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; Those who voluntarily participate in the trial and sign the informed consent. Exclusion criteria: Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels; Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system; Use chemotherapy or radiotherapy within 3 days before the blood collection period; Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids); Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period; Those who have previously used any gene therapy products; History of epilepsy or other diseases of the central nervous system; New York Heart Association (NYHA) class III or above (see Annex 3); creatinine> 1.5 times the upper limit of normal or ALT / AST> 3 times the upper limit of normal or bilirubin> 2 times the normal upper limit; active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections; pregnant or lactating women; suffer from other uncontrolled diseases that the researcher considers inappropriate; Any condition that the investigator believes may increase the subject's risk or interfere with the test results.

Central Contact Person:

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

Xin-an Lu, Dr

Phone

86-189-1157-6946

luxinan@immunochina.com

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

Xinan Lu, Dr.

First Name & Middle Initial & Last Name & Degree

Jun Zhu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34515338

Citation

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Results Reference

derived

PubMed Identifier

33632155

Citation

Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1.

Results Reference

derived

Learn more about this trial

Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients

We'll reach out to this number within 24 hrs