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Trial Title:
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
NCT ID:
NCT05806099
Condition:
Non-Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1/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:
Drug
Intervention name:
MBS303
Description:
Phase I: The patients confirming to the eligibility criteria will be assigned to one of
the 7 dose groups (0.05/0.15/0.45 mg ~ 1.5/6/60 mg, respectively) based on the sequence
of inclusion. Each patient will receive MBS303 as per the schedule specified in the
respective arms. Based on the safety data of the previous dose groups, if pretreatment
with MIL62 is required after disussion by the sponsor and the investigators, the subject
should be given an IV infusion of MIL62 1000 mg single dose on the D-7.
Phase Ⅱ: One or two recommended doses will be selected based on the results of Phase I.
Each patient will receive one of the two recommended doses MBS303 as step-up doses on D1
(low dose) and D8 (intermediate dose) of C1 and at the target dose on D1 of C2-17 (21-day
cycles). Based on the previous safety data, if pretreatment with MIL62 is required after
disussion by the sponsor and the investigators, the subjects should be given an IV
infusion of MIL62 1000 mg single dose on the D-7
Arm group label:
MBS303
Summary:
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate
the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a
novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in
participants with relapsed or refractory B-cell NHL. This entry-to-human study consists
of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide written informed consent and to comply with the study
protocol.
2. Adult patients, ≥18 years of age;
3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at
least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom
there is no available therapy expected to improve survival;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Life expectancy ≥3 months;
6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal
lesion, defined as >1.5 cm in its longest dimension, or at least one
bi-dimensionally measureable extranodal lesion, defined as >1.0 cm in its longest
dimension
7. Adequate hematologic, hepatic, and renal function.
Exclusion Criteria:
1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
2. History of central nervous system (CNS) lymphoma or other CNS disease;
3. Participants with known active infection, including bacterial, viral, parasite,
mycobacterial, or other infections (excluding nail bed fungal infections);
4. Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor
embolization, or other antitumor therapy within 28 days prior to the first MBS303;
5. Active or suspected autoimmune diseases;
6. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
7. Evidence of significant, uncontrolled concomitant disease;
8. Major surgery within 28 days prior to the first MBS303 administration or expected to
undergo major surgery during the study treatment;
9. History of another invasive malignant tumors in past 3 years;
10. Participant with history of confirmed progressive multifocal leukoencephalopathy
(PML);
11. Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia,
or spontaneous bleeding requiring blood transfusion or other medical intervention;
12. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
(including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
13. Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to
use two reliable forms of contraception simultaneously or to practice complete
abstinence from heterosexual contact during the following time periods related to
this study: 1) while participating in the study; 2) for at least 12 months after
discontinuation of all study treatments.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song, Doctor
Phone:
8610-88196118
Email:
SongYQ_VIP@163.com
Start date:
June 28, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Beijing Mabworks Biotech Co., Ltd.
Agency class:
Industry
Source:
Beijing Mabworks Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806099
