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Trial Title:
Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
NCT ID:
NCT05744037
Condition:
B-cell Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma, B-Cell
Conditions: Keywords:
BTK inhibitor
Anti CD19 CAR-T cells
Study type:
Interventional
Study phase:
Phase 2
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:
regimen with BTK inhibitor +Anti-CD19 CAR T cells
Description:
After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide
(750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0.
The dose was determined by the investigator according to the subjects' own disease
conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30
minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.
Arm group label:
CAR-T Cell Infusion
Summary:
To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T
cells.
Detailed description:
The most successful application of CAR-T cell technology in clinical practice is for the
treatment of hematologic malignancies, which may be related to the strong specificity of
tumor-associated antigen and the weak immunosuppressive effect of tumor microenvironment.
CD19 is specifically expressed in B cells and is expressed in all stages of B-cell
development and differentiation and in most B-cell tumors, but not in hematopoietic stem
cells and other cells. CD19 is a promising target for B-cell tumors and is currently a
hot spot in CAR studies.
Antigen-dependent BCR signaling is involved in several downstream pathways, including
NF-kB pathway and PI3K/AKT/mTOR pathway, which can promote B cell survival. BTK
inhibitors can jointly inhibit the survival of tumor cells by promoting apoptosis and
inhibiting the proliferation of tumor cells, reducing the adhesion of tumor cells, and
inhibiting chemokines to prevent the migration of B cells.
In this study, BTKi (Ibrutinib) combined with Anti-CD19 CAR-T cells were proposed to
treat RR B-NHL, with the main purpose of observing the efficacy and safety of this
regimen in patients with relapsed and refractory B-NHL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients or their legal guardians voluntarily participate and sign the informed
consent;
2. Male or female patients aged 18-70 years old;
3. CD19+ B-NHL was confirmed by pathology and histology, and the patient had no
effective treatment options at present, such as chemotherapy or hematopoietic stem
cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19
CAR T as salvage therapy;
4. Subjects showed residual lesions after major treatment and were not suitable for
HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk
factors; Relapse or no remission after hematopoietic stem cell transplantation or
cellular immunotherapy;
5. Have measurable or evaluable lesions;
6. The patient's main tissues and organs function well;
7. The patient's peripheral shallow venous blood flow is smooth, which can meet the
needs of intravenous drip.
8. Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75
years.
Exclusion Criteria:
1. Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding;
2. Men or women who have planned to get pregnant within the last 1 year;
3. The patients were not guaranteed to take effective contraceptive measures (condom or
contraceptive, etc.) within 1 year after enrollment;
4. Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
5. Active hepatitis B/C virus;
6. HIV-infected patients;
7. Suffering from a serious autoimmune disease or immunodeficiency disease;
8. The patient is allergic to antibodies, cytokines and other macromolecular biological
drugs;
9. The patient had participated in other clinical trials within 6 weeks prior to
enrollment;
10. Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled
hormones);
11. Suffering from mental illness;
12. The patient has substance abuse/addiction;
13. According to the researchers' judgment, the patient had other conditions that were
not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221002
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Sang, M.D., Ph.D.
Phone:
13645207648
Email:
xyfylbl515@xzhmu.edu.cn
Start date:
January 1, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Source:
The Affiliated Hospital of Xuzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05744037
