Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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:

∙ 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;

• 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;

• The expected survival period is ≥12 weeks;

• The puncture section of the tumor tissue was positive for CD19 expression;

• ECOG score 0-2 points;

• Sufficient organ function reserve:

∙ Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);

‣ Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;

‣ Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;

‣ Glomerular filtration rate\>50Ml/min

‣ Cardiac ejection fraction (EF) ≥50%;

‣ Under natural indoor air environment, basic oxygen saturation\>92%

• Allow a previous stem cell transplantation

⁃ The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;

⁃ Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;

⁃ Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial

⁃ Two tests for the new coronavirus or swine flu virus are negative.

Locations
Other Locations
China
the Second Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Wenbin Qian, Professor
qianwb@zju.edu.cn
+8613605801032
Backup
Hui Liu, Professor
sylen@zju.edu.cn
13819198629
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 52
Treatments
Experimental: CD19-CAR-NK/T
All subjects were intravenously administrated with CAR-NK019 at day 0 with a dose of 2x10\^6/kg, and after 1 week will be infused with 7x19 CAR-T at the dose of 2x10\^6/kg
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov