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Trial Title:
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
NCT ID:
NCT06346912
Condition:
Acute Lymphoblastic Leukemia,B-Cell
Non-hodgkin Lymphoma,B Cell
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, B-Cell
Leukemia, B-Cell
Conditions: Keywords:
CD19-BAFF CAR-T
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
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-BAFF Targeted CAR T-cells
Description:
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
Arm group label:
Administration of CD19-BAFF Targeted CAR T-cells
Other name:
CD19-BAFF Targeted CAR T-cells injection
Summary:
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for
refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
Detailed description:
In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were
proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has
been clarified in previous studies, further observation and evaluation of the
effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and
B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data
on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were
accumulated, including rare and delayed complications.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Gender unlimited，18< Age;
-
2. Patients diagnosed with B-cell acute lymphoblastic leukemia through
histological or immunophenotyping tests; The clear diagnosis of B-cell non
Hodgkin's lymphoma by cellular or histopathological examination mainly includes
diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma
-
3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12
months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
-
4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow
is >5% (by morphology), and/or >1% (by flow cytometry);
-
5. Philadelphia-chromosome-negative (Ph-) patients; or
Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI
treatments or do not respond to 2 TKI treatments;
-
6. Relapsed or refractory B-NHL (meeting one of the following conditions):
1. No response or relapse after second-line or above chemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
-
7. At least one assessable tumor lesion per Lugano 2014 criteria;
-
8. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal,
creatinine ≤ 176.8 umol/L;
-
9. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
-
10. No active infection in the lungs, blood oxygen saturation in indoor air is ≥
92%;
-
11. Estimated survival time ≥ 3 months;
-
12. ECOG performance status 0 to 2;
-
13. Patients or their legal guardians volunteer to participate in the study and
sign the informed consent.
Exclusion Criteria:
-
1. History of craniocerebral trauma, conscious disturbance, epilepsy,
cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
-
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as
severe arrhythmia in the past;
-
3. Pregnant/lactating women, or male or female patients with fertility who are
unwilling to take effective contraceptive measures during the study period or
at least 6 months after the last cell infusion
-
4. Patients with HIV infection;
-
5. Active infection of hepatitis B virus or hepatitis C virus;
-
6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation
signal;
-
7. Other uncontrolled diseases that were not suitable for this trial;
-
8. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene
modified cell therapy product within 6 months;
-
9. Any situations that the investigator believes may increase the risk of patients
or interfere with the results of study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of medical college of zhejiang university
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, MD
Phone:
86-13605714822
Email:
hehuangyu@126.com
Contact backup:
Last name:
Yongxian Hu, MD
Phone:
+8615957162012
Email:
huyongxian2000@aliyun.com
Start date:
May 30, 2024
Completion date:
May 30, 2027
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Shanghai YaKe Biotechnology Ltd.
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06346912
