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

Early Phase I Interventional Infectious Diseases Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LMP1 CAR T-cells.
Who it may be relevant to
Registry conditions: Infectious Diseases, Hematological Malignancies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Trial for the Safety and Efficacy of Sequential of LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

Overview

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.

Interventions

  • Drug LMP1 CAR T-cells
    Each subject receive LMP1 CAR T-cells by intravenous infusion

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Baseline up to 28 days after LMP1 targeted CAR T-cells infusion]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after LMP1 targeted CAR T-cells infusion]
Secondary outcome measures (12)
  • Chronic active EB virus infection (CAEBV), Overall response rate (ORR) [Time frame: At Month 1, 3, 6, 12, 18 and 24]
  • CAEBV，Duration of remission（DOR） [Time frame: Up to 2 years after LMP1 CAR-T cells infusion]
  • CAEBV, Overall survival (OS) [Time frame: Up to 2 years after LMP1 CAR-T cells infusion]
  • CAEBV, Relapse rate(RR) [Time frame: At Month 6, 12, 18 and 24]
  • CAEBV, Event-free survival (EFS) [Time frame: Up to 2 years after LMP1 CAR-T cells infusion]
  • Hodgkin's lymphoma(HL), Extranodal NK/T cell lymphoma(ENKTL),Nasal type, Lymphoproliferative disease after hematopoietic stem cell transplantation, (post-HSCT PTLD),Overall response rate (ORR) [Time frame: At Month 1, 3, 6, 12, 18 and 24]
  • HL, ENKTL, PTLD, OS [Time frame: Up to 2 years after LMP1 CAR-T cells infusion]
  • HL, ENKTL, PTLD, EFS [Time frame: Up to 2 years after LMP3 CAR-T cells infusion]
  • Quality of life [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Activities of Daily Living (ADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Instrumental Activities of Daily Living (IADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Hospital Anxiety and Depression Scale (HADS) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]

Eligibility criteria

Inclusion criteria

Only applicable to the inclusion criteria of CAEBV

  • 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;
  • All CAEBV patients who have not achieved complete remission, including:
  • 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;
  • inactive phase: EBV-DNA level in PBMC is higher than 1×10\^2.5 copies/μg DNA, without symptoms and signs of active diseases;
  • The disease has not yet progressed to hematopoietic lymphohistiocytosis (HLH);

Only applicable to the inclusion criteria of LMP1-positive ENKTL:

  • 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;
  • R/R ENKTL (meets one of the following prerequisites)
  • Without remission or with progression after receiving second-line or higher-line chemotherapy/chemotherapy + radiotherapy;
  • Primary drug resistance;
  • With recurrence after receiving autologous/allogeneic hematopoietic stem cell transplantation;
  • According to 2014 Lugano standard, there should be at least one evaluable tumor lesion.

Only applicable to the inclusion criteria for LMP1-positive HL:

  • According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with Hodgkin lymphoma diagnosed by histopathology (HD) and LMP1 positive in tumor tissue;
  • R/R HD (meets one of the following prerequisites):
  • Without remission or with progression after receiving second-line or higher-line chemotherapy;
  • Primary resistance Drugs;
  • With recurrence after receiving autologous hematopoietic stem cell transplantation;
  • According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion;

Only applicable to the inclusion criteria for LMP1-positive PTLD:

  • Only PTLD after hematopoietic stem cell transplantation;
  • According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with PTLD diagnosed by histopathology and LMP1 positive in tumor tissue;
  • Excluding PTLD of early-stage
  • R/R PTLD (meets one of the following prerequisites):
  • Without remission or with progression after receiving rituximab-based standard treatment;
  • Primary drug resistance;
  • According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion

Exclusion criteria

Subjects with any of the following exclusion criteria were not eligible for this trial:

  • History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  • Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
  • Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT04657965 · LMP1-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗