Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma

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 efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years old, no gender limit;

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 ;

Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;

Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;

Disqualifiers

Allergic to any of the components of cell products;

History of other tumors;

Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;

Had received gene therapy within the past 3 months;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19-CAR-NK/T

    Biological/Vaccine

    Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: CD19-CAR-NK/TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLTs)

To evaluate the safety and tolerability of cord blood-derived anti-CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 28 days

Secondary outcomes

1

Overall survival (OS)

To determine the OS of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 2 years
2

Progression free survival (PFS)

To determine the anti-tumor efficacy of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 2 years
3

Duration of response (DOR)

To determine the DOR of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 2 years
4

Complete response rate (CR)

To determine the CR rate of CB CD19 CAR-NK Cell sequential with 7X19 CAR-T for B-cell Non-Hodgkin Lymphoma

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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