Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy

Pell Bio-Med Technology

Status: Enrolling

Conditions: Primary Mediastinal Large B Cell Lymphoma; Large B-cell Lymphoma; Follicular Lymphoma Grade 3A; Diffuse Large B Cell Lymphoma; Follicular Lymphoma Grade 3B

Treatments: Genetic: Pell's lentiviral-based gene-edited immune cell therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05377307

PLLV-LTFU-401

Details and patient eligibility

About

According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.

Full description

After completion or early withdraw from the other treatment protocol, patients should be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.

Enrollment: 49 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.
2. The last lentiviral-based gene-edited immune cell infusion within 15 years.
3. Patient/patient's parent/legal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

There are no specific exclusion criteria for this study.

Trial design

49 participants in 2 patient groups

Group A

Description:

After completion or early withdraw from the treatment protocol, patients will be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.

Treatment:

Genetic: Pell's lentiviral-based gene-edited immune cell therapy

Group B

Description:

Some patients may require joining other Pell's gene-edited immune cell therapy study during participating in this long-term follow-up study. For such case, the patient could be enrolled into the new treatment protocol. Meanwhile, the patient can be remaining in this long-term follow-up protocol as an inactive participant.

Treatment:

Genetic: Pell's lentiviral-based gene-edited immune cell therapy