LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

NCT ID: NCT04657965

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2027-01-15

Brief Summary

A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for LMP1 positive infectious diseases and hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 144 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Conditions

Infectious Diseases; Hematological Malignancies

Keywords

Infectious diseases; Hematological Malignancies; CAR T-cell therapy; LMP1

Study Design

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

Study Groups

Administration of LMP1 CAR T-cells

Each subject receive LMP1 CAR T-cells by intravenous infusion

Group Type: EXPERIMENTAL

LMP1 CAR T-cells

Intervention Type: DRUG

Each subject receive LMP1 CAR T-cells by intravenous infusion

Interventions

LMP1 CAR T-cells

Each subject receive LMP1 CAR T-cells by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

LMP1 CAR-T cells injection

Eligibility Criteria

Inclusion Criteria

1. Subjects who are diagnosed with CAEBV according to the Okano revised standard proposed by the Japanese Ministry of Health, Labour and Welfare Research Group for the Prevention of Refractory Diseases;

2. All CAEBV patients who have not achieved complete remission, including:

1. Active phase: EBV-DNA level in PBMC is higher than 1×10^2.5 copies/μg DNA, with symptoms and signs of active diseases such as fever, hepatomegaly, splenomegaly, abnormal liver function, decrease of blood three lines, lymphadenopathy, and progressive skin lesions with increased EBV titer in peripheral blood;

2. inactive phase: EBV-DNA level in PBMC is higher than 1×10^2.5 copies/μg DNA, without symptoms and signs of active diseases;

3. The disease has not yet progressed to hematopoietic lymphohistiocytosis (HLH);

1. According to the 2016 WHO classification criteria for lymphocytic tumors: Subjects diagnosed by histopathology as extranodal NK/T cell lymphoma, nasal type (ENKTL) with LMP1 positive in tumor tissue;

2. R/R ENKTL (meets one of the following prerequisites)

1. Without remission or with progression after receiving second-line or higher-line chemotherapy/chemotherapy + radiotherapy;

2. Primary drug resistance;

3. With recurrence after receiving autologous/allogeneic hematopoietic stem cell transplantation;

3. According to 2014 Lugano standard, there should be at least one evaluable tumor lesion.

1. According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with Hodgkin lymphoma diagnosed by histopathology (HD) and LMP1 positive in tumor tissue;

2. R/R HD (meets one of the following prerequisites):

1. Without remission or with progression after receiving second-line or higher-line chemotherapy;

2. Primary resistance Drugs;

3. With recurrence after receiving autologous hematopoietic stem cell transplantation;

3. According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion;

1. Only PTLD after hematopoietic stem cell transplantation;

2. According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with PTLD diagnosed by histopathology and LMP1 positive in tumor tissue;

3. Excluding PTLD of early-stage

4. R/R PTLD (meets one of the following prerequisites):

1. Without remission or with progression after receiving rituximab-based standard treatment;

2. Primary drug resistance;

5. According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion

Exclusion Criteria

1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

3. Pregnant (or lactating) women;

4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

5. Active infection of hepatitis B virus or hepatitis C virus;

6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;

7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;

8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

9. Other uncontrolled diseases that were not suitable for this trial;

10. Patients with HIV infection;

11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

He Huang, PhD

Role: CONTACT

Phone: 86-13605714822

Email: hehuangyu@126.com

Yongxian Hu, PhD

Role: CONTACT

Phone: 86-15957162012

Email: huyongxian2000@aliyun.com

Other Identifiers

LMP1-001

Identifier Type: -

Identifier Source: org_study_id