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Trial Title:
Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma
NCT ID:
NCT06464861
Condition:
Primary Mediastinal B-cell Lymphoma (PMBCL)
Mantle Cell Lymphoma (MCL)
Diffuse Large B Cell Lymphoma( DLBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD19-CAR-NK/T
Description:
Cord blood derived CD19 CARNK sequential Treatment with 7x19 CAR-T
Arm group label:
CD19-CAR-NK/T
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
Detailed description:
This is a single-center, open, single-arm clinical exploratory study to observe the
safety and efficacy of cord blood derived CD19 CAR-NK cells sequential treatment with
7x19 CAR-T in relapse / refractory B cell lymphoma. This study consisted of two phases:
phase I: CARNK cells preparation and infusion (Day0, dose of 2 x 10^6 / kg). Phase II:
7x19 CAR-T cells preparation and infusion (Day7, dose 2×10^6/kg).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old, no gender limit;
2. 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;
3. Previous treatment must include CD20 monoclonal antibody treatment (unless the
subject is CD20 negative) and anthracyclines;
4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
5. The expected survival period is ≥12 weeks;
6. The puncture section of the tumor tissue was positive for CD19 expression;
7. ECOG score 0-2 points;
8. Sufficient organ function reserve:
1. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of
normal value);
2. Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
3. Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
4. Glomerular filtration rate>50Ml/min
5. Cardiac ejection fraction (EF) ≥50%;
6. Under natural indoor air environment, basic oxygen saturation>92%
9. Allow a previous stem cell transplantation
10. 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;
11. Allow patients who have previously received CAR-T cell therapy and have failed or
relapsed after 3 months of evaluation;
12. Female subjects of childbearing age must have a negative pregnancy test and agree to
take effective contraceptive measures during the trial
13. Two tests for the new coronavirus or swine flu virus are negative.
Exclusion Criteria:
1. Allergic to any of the components of cell products;
2. History of other tumors;
3. Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the
past or are receiving anti-GVHD treatment;
4. Had received gene therapy within the past 3 months;
5. Active infections requiring treatment (except for simple urinary tract infections,
bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal
infection treatment are permitted;
6. Patents infected with hepatitis B (HBsAg positive, but HBV-DNA < 103 is not
excluded) or hepatitis C virus (including virus carriers), syphilis and other
acquired and congenital immunodeficiency diseases, including but not limited to
HIV-infected persons;
7. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart
Association's cardiac function grading criteria;
8. Patients who received antitumor therapy earlier but did not recover from the
toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia,
alopecia);
9. Subjects with a history of epilepsy or other central nervous system disorders;
10. Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;
11. Lactating women who are unwilling to stop breastfeeding;
12. Any other factors that the investigator believes may increase the risk to the
subject or interfere with the test results.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 10, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464861
