Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

To study the safety and effectiveness of cord blood-derived IL-10/IL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to participate in this study and sign an informed consent form;

Age 18-75 years old, no gender limit;

Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:(1) Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ; (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;

At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;

Disqualifiers

Those who have a history of allergies to any of the ingredients in cell products;

History of other tumors;

Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;

Have received gene therapy in the past 3 months;

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-CD19 IL10/IL15 CAR-NK

    Biological/Vaccine

    Lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19-IL10/IL-15 CAR

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: CB IL-10/IL-15-CD19-CAR NKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLTs)

To evaluate the safety, and tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 IL10/IL15-CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 28 days

Secondary outcomes

1

Complete response rate (CR)

To determine the anti-tumor effectivity of CB IL-10-CD19-CAR NK

Time frame
Up to 2 years
2

Progression free survival (PFS)

Time frame
Up to 2 years
3

Duration of response (DOR)

Time frame
Up to 2 years
4

Overall survival (OS)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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