Non-Hodgkin's LymphomaPhase 1/2NCT05806099
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
A Phase 1/2 study testing MBS303 in people with Non-Hodgkin's Lymphoma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- MBS303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the study protocol.
- Adult patients, ≥18 years of age;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥3 months;
- 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
- Adequate hematologic, hepatic, and renal function.
Who cannot join
- Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
- History of central nervous system (CNS) lymphoma or other CNS disease;
- Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
- Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
- Active or suspected autoimmune diseases;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
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- Evidence of significant, uncontrolled concomitant disease;
- Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
- History of another invasive malignant tumors in past 3 years;
- Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
- Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Yuqin Song, Doctor, 8610-88196118, SongYQ_VIP@163.com
About this study
Official title: A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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)
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- MBS303
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS303Drug
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
| Study group | Role | What they receive |
|---|---|---|
| MBS303 | Experimental | Not described Receives: Drug: MBS303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I：Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0
Measured: From Baseline up to approximately 13 months
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Measured: From Baseline up to 3 weeks
Phase I：Maximum Tolerated Dose (MTD) of MBS303
Measured: From Baseline up to 3 weeks
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303
Measured: From Baseline up to 4 years
Phase Ⅱ ：Antitumor activity as measured by the objective response rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (10)
Phase I and Ⅱ ：Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of MBS303 after the administration
Measured: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: t1/2
Half-life (t1/2) of MBS303 after administration
Measured: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: CL
Clearance (CL) of MBS303 after administration
Measured: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: Vd
Volume of distribution (Vd) of MBS303 after administration
Measured: up to approximately 1 year
Phase I and Ⅱ ：Efficacy: Complete Response Rate (CRR) of MBS303 as Assessed Using Standard Criteria for NHL
Measured: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Duration of Response (DOR) of MBS303 as Assessed Using Standard Criteria for NHL
Measured: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Progression-Free Survival (PFS) of MBS303 as Assessed Using Standard Criteria for NHL
Measured: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Overall Survival (OS) of MBS303
Measured: Up to approximately 2 years
Phase I and Ⅱ ：Immunogenicity: Anti-Drug Antibodies (ADA) to MBS303
Measured: Up to approximately 1 year
Phase I :Efficacy: ORR
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start28 Jun 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Beijing Mabworks Biotech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806099
- Sponsor's protocol ID
- MBS303-CT101
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05806099
- Acronym / sponsor ID
- MBS303-CT101
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Beijing Mabworks Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBS303 | Experimental | Drug: MBS303 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide written informed consent and to comply with the study protocol.
- Adult patients, ≥18 years of age;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥3 months;
Key exclusion criteria (13 listed)
- Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
- History of central nervous system (CNS) lymphoma or other CNS disease;
- Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
- Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
- Active or suspected autoimmune diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBS303Phase 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 | Drug | MBS303 |
Primary outcome
Phase I：Percentage of Participants with Adverse Events (AEs)
Time frame: From Baseline up to approximately 13 months
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
Time frame: From Baseline up to 3 weeks
Phase I：Maximum Tolerated Dose (MTD) of MBS303
Time frame: From Baseline up to 3 weeks
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303
Time frame: From Baseline up to 4 years
Phase Ⅱ ：Antitumor activity as measured by the objective response rate (ORR)
Time frame: Up to approximately 2 years
10 secondary outcomes
Phase I and Ⅱ ：Pharmacokinetics: AUC
Time frame: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: t1/2
Time frame: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: CL
Time frame: up to approximately 1 year
Phase I and Ⅱ ：Pharmacokinetics: Vd
Time frame: up to approximately 1 year
Phase I and Ⅱ ：Efficacy: Complete Response Rate (CRR) of MBS303 as Assessed Using Standard Criteria for NHL
Time frame: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Duration of Response (DOR) of MBS303 as Assessed Using Standard Criteria for NHL
Time frame: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Progression-Free Survival (PFS) of MBS303 as Assessed Using Standard Criteria for NHL
Time frame: Up to approximately 2 years
Phase I and Ⅱ ：Efficacy: Overall Survival (OS) of MBS303
Time frame: Up to approximately 2 years
Phase I and Ⅱ ：Immunogenicity: Anti-Drug Antibodies (ADA) to MBS303
Time frame: Up to approximately 1 year
Phase I :Efficacy: ORR
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MBS303 in people with Non-Hodgkin's Lymphoma, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song, Doctor (8610-88196118, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I：Percentage of Participants with Adverse Events (AEs) (time frame: From Baseline up to approximately 13 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.