AzTrials
AzTrials

Infectious DiseasesEarly Phase 1NCT04657965

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

A Early Phase 1 study testing LMP1 CAR T-cells in people with Infectious Diseases and Hematological Malignancies, run by Zhejiang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Any age
What is being tested?
LMP1 CAR T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
15 Jan 2021to 15 Jan 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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);
Show all 28Show fewer
  • 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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

He Huang, PhD contact

86-13605714822

hehuangyu@126.com

Yongxian Hu, PhD contact

86-15957162012

huyongxian2000@aliyun.com

China1 site

  • The First Affiliated Hospital，College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

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

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.

Being tested
LMP1 CAR T-cells
Keywords
Infectious diseases, Hematological Malignancies, CAR T-cell therapy, LMP1
Medical subject headings
Communicable Diseases, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LMP1 CAR T-cellsDrug

    Also called LMP1 CAR-T cells injection

    Each subject receive LMP1 CAR T-cells by intravenous infusion

Study groups in NCT04657965
Study groupRoleWhat they receive
Administration of LMP1 CAR T-cellsExperimentalEach subject receive LMP1 CAR T-cells by intravenous infusion
Receives: Drug: LMP1 CAR T-cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

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

    Measured: 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]

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

Secondary outcomes (12)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: At Baseline, Month 1, 3, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start15 Jan 2021 (estimated)
  3. Primary completion15 Jan 2024 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657965
Sponsor's protocol ID
LMP1-001
Status last verified
Dec 2020
First submitted
22 Oct 2020
Last updated
8 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LMP1 CAR T-cells in people with Infectious Diseases and Hematological Malignancies, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after LMP1 targeted CAR T-cells infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in