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

ConditionsInfectious DiseasesHematological Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Active phase: EBV-DNA level in PBMC is higher than 1×10².5 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 1×10².5 copies/μg DNA, without symptoms and signs of active diseases;

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

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • LMP1 CAR T-cells

    Drug

    Each subject receive LMP1 CAR T-cells by intravenous infusion

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: Administration of LMP1 CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: