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Not yet recruitingNCT04657965Updated Dec 8, 2020

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

An Early Phase 1 interventional study of LMP1 CAR T-cells in Infectious Diseases and Hematological Malignancies, sponsored by Zhejiang University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Zhejiang University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
144
Allocation
Not applicable
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Infectious Diseases
  • Hematological Malignancies

Keywords

  • Infectious diseases
  • Hematological Malignancies
  • CAR T-cell therapy
  • LMP1
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 144 is above the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Only applicable to the inclusion criteria of CAEBV

  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);

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

  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.

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

  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;

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

  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

Exclusion Criteria:

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

  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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Administration of LMP1 CAR T-cells

    Each subject receive LMP1 CAR T-cells by intravenous infusion

    Drug: LMP1 CAR T-cells

Interventions

  • DrugLMP1 CAR T-cells

    Each subject receive LMP1 CAR T-cells by intravenous infusion

    Also known as: LMP1 CAR-T cells injection

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Time frame: Baseline up to 28 days after LMP1 targeted CAR T-cells infusion

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Time frame: Up to 2 years after LMP1 targeted CAR T-cells infusion

Secondary outcomes

  1. Chronic active EB virus infection (CAEBV), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + PR) at Month 1, 3, 6, 12, 18 and 24

    Time frame: At Month 1, 3, 6, 12, 18 and 24

  2. CAEBV，Duration of remission（DOR）

    From the first remission after LMP1 CAR-T cells to relapse, death or the last visit

    Time frame: Up to 2 years after LMP1 CAR-T cells infusion

  3. CAEBV, Overall survival (OS)

    From the first infusion of LMP1 CAR-T cells to death or the last visit

    Time frame: Up to 2 years after LMP1 CAR-T cells infusion

  4. CAEBV, Relapse rate(RR)

    From the first remission after LMP1 CAR-T cells to relapse or the last visit

    Time frame: At Month 6, 12, 18 and 24

  5. CAEBV, Event-free survival (EFS)

    From the first infusion of LMP1 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

    Time frame: Up to 2 years after LMP1 CAR-T cells infusion

  6. 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)

    Assessment of ORR (ORR = CR + PR) at Month 1, 3, 6, 12, 18 and 24

    Time frame: At Month 1, 3, 6, 12, 18 and 24

  7. HL, ENKTL, PTLD, OS

    From the first infusion of LMP1 CAR-T cells to death or the last visit

    Time frame: Up to 2 years after LMP1 CAR-T cells infusion

  8. HL, ENKTL, PTLD, EFS

    From the first infusion of LMP1 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

    Time frame: Up to 2 years after LMP3 CAR-T cells infusion

  9. Quality of life

    Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  10. Activities of Daily Living (ADL) score

    Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  11. Instrumental Activities of Daily Living (IADL) score

    Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  12. Hospital Anxiety and Depression Scale (HADS) score

    Assessment using Hospital Anxiety and Depression Scale (HADS) \[max score: 42, min score: 0, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

07

Study locations

1 site
  • The First Affiliated Hospital，College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04657965
Lead sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
Responsible party
He Huang (Clinical Professor, Zhejiang University) — Principal investigator
First posted
Dec 8, 2020
Start date
Jan 15, 2021 (estimated)
Primary completion
Jan 15, 2024 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Dec 8, 2020

Study contacts

He Huang, PhD
Contact
hehuangyu@126.com
86-13605714822
Yongxian Hu, PhD
Contact
huyongxian2000@aliyun.com
86-15957162012

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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