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

Non Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03528421
• Other study ID #: YMCART201705
• Status: Recruiting
• Phase: Phase 1
• Start date: May 22, 2018
• Est. completion date: May 2020

Study information

• Verified date: May 2018
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Xin-an Lu, Dr
• Phone: 86-189-1157-6946
• Email: luxinan[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Biological:
• IM19
CAR-T cells

Drug:
• Fludarabine
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
• Cyclophosphamide
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.	Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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)	2 years