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

NCT ID: NCT03528421

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2020-05-31

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

1. Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.

2. According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.

Conditions

Non Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IM19 CAR-T cells

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

Group Type: EXPERIMENTAL

IM19

Intervention Type: BIOLOGICAL

CAR-T cells

Fludarabine

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

Interventions

IM19

CAR-T cells

Intervention Type: BIOLOGICAL

Fludarabine

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

Intervention Type: DRUG

Cyclophosphamide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients must have evaluable disease evidence;

3. Age ≥ 18 years old;

4. The expected life span is more than 3 months;

5. ECOG score 0-2 points (see Attachment 2);

6. 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;

7. Those who voluntarily participate in the trial and sign the informed consent.

Exclusion Criteria

1. Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;

2. Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;

3. Use chemotherapy or radiotherapy within 3 days before the blood collection period;

4. Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);

5. Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;

6. Those who have previously used any gene therapy products;

7. History of epilepsy or other diseases of the central nervous system;

8. New York Heart Association (NYHA) class III or above (see Annex 3);

9. 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;

10. active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;

11. pregnant or lactating women;

12. suffer from other uncontrolled diseases that the researcher considers inappropriate;

13. Any condition that the investigator believes may increase the subject's risk or interfere with the test results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin-an Lu, Dr

Role: CONTACT

luxinan@immunochina.com

86-189-1157-6946

Facility Contacts

Xinan Lu, Dr.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 34515338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33632155 (View on PubMed)

Other Identifiers

YMCART201705

Identifier Type: -

Identifier Source: org_study_id