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Trial Title:
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
NCT ID:
NCT05741359
Condition:
Non-hodgkin Lymphoma,B Cell
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Total target count of CD3+CAR+ viable cells
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
Description:
CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection
Arm group label:
Treatment group
Other name:
BRL-201
Summary:
This is a multi-center, single-arm, open-label clinical study, and the sample size is set
to 12-18 subjects.
Detailed description:
This is a multi-center, single-arm, open-label clinical study, and the sample size is set
to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will
be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group
C. Additional subjects will be enrolled into the RP2D group to ensure that 6-9
efficacy-evaluable subjects are available in the RP2D group before entering the phase II
study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willing to participate in this clinical study and sign an informed consent form;
2. Age ≥ 18 years old;
3. Estimated survival time ≥ 3 months;
4. Presence of at least one measurable lesion as assessed according to Lugano
Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional
images obtained by CT show that the long diameter of lymph node lesions is > 15 mm
or the long diameter of extranodal lesions is > 10 mm, and FDG-PET scan results are
positive). Lesions, for which radiotherapy was provided, can be regarded as
measurable lesions only if there is an unequivocal progression after radiotherapy;
5. Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in
tumors detected by immunohistochemistry or flow cytometry; pathological types of
B-NHL (according to WHO Lymphoma Classification 2016);
6. Relapsed or refractory diseases;
7. Subjects who must receive adequate prior therapy;
8. Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic
resonance imaging (MRI);
9. Hematological parameters meeting the requirements;
10. Blood biochemistry meeting the requirements;
11. LVEF ≥ 55%;
12. No severe pulmonary disorders;
13. Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved
to grade ≤ 1;
14. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
15. Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to
abide by the rules formulated in the study protocol.
Exclusion Criteria:
1. Pregnant or lactating women;
2. Subjects who previously received allogeneic cell therapies, including allogeneic
stem cell transplant;
3. Subjects who previously received anti-CD19 targeted therapy, except those who
receive BRL-201 and are eligible to receive reinfusion in this study;
4. Prior treatment with any CAR-T cell product or other genetically modified T cell
therapies;
5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);
6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring
systemic therapy. Patients can be enrolled if the simple urinary tract infection or
pharyngitis responds to treatment;
7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core
antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of
detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA
positive; human immunodeficiency virus (HIV) antibody positive; syphilis test
positive;
8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure,
cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any
CNS-involved autoimmune disorders);
9. Active autoimmune disorders requiring immunotherapy, including but not limited to
end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid
arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring
systemic application of immunosuppressive drugs or other drugs for systemic control
of diseases;
10. Primary immunodeficiency;
11. History of other malignancies;
12. Patients with severe cardiovascular disorders, including but not limited to those
with lymphoma infiltration in the cardiac atrium or ventricles and those with a
history of myocardial infarction, cardioangioplasty or stent implantation, unstable
angina, or other clinically significant heart diseases within 12 months before
enrollment;
13. History of deep venous thrombosis or pulmonary embolism within 6 months before
enrollment;
14. Patients who are receiving oral anticoagulant therapy; prothrombin time (PT),
activated partial thromboplastin time (APTT), or international normalized ratio
(INR) > 1.5 × ULN without anticoagulant therapy;
15. Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous
nephrostomy, indwelling catheter, or catheter in pleural cavity/peritoneal
cavity/pericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or
Hickman catheter) are permitted;
16. Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases,
history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal
fluid or brain metastases;
17. Conditions (e.g., intestinal obstruction or vascular compression) requiring
emergency treatment due to tumor masses;
18. History of severe immediate hypersensitivity to any drug to be used in this study;
19. Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19)
vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;
20. Any circumstances that possibly increase the risk of subjects or interfere with the
study results as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Heng Mei, PhD
Facility:
Name:
Tianjin Institute of Hematology
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Rugui qiu, PhD
Facility:
Name:
The First Affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, PhD
Start date:
April 25, 2023
Completion date:
March 15, 2024
Lead sponsor:
Agency:
Bioray Laboratories
Agency class:
Industry
Collaborator:
Agency:
Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Bioray Laboratories
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05741359
