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CLL/SLLPhase 1/2NCT05365100

A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL

A Phase 1/2 study testing BN102 in people with CLL/SLL and NHL, run by BioNova Pharmaceuticals (Shanghai) LTD. at 6 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin's Lymphoma (NHL) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL/SLL, NHL
What is being tested?
BN102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesChina
Study dates
Jul 2022to 30 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • All of the following conditions must be met for subject enrollment:
  • Have fully understood and voluntarily signed the informed consent form ;
  • Age ≥ 18 years;
  • In phase 1, subjects with histologically confirmed CLL/SLL or B-cell NHL who are relapsed/refractory or intolerable after at least 1 prior line of adequate therapy, and have no better treatment choice as assessed by the investigator;
  • In Phase 2, the 6 cohorts had the following specific enrollment criteria and required further treatment:
  • Cohort 1: histologically confirmed MCL, failure or intolerance to at least one prior treatment including BTK inhibitor;
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  • Cohort 2: histologically confirmed MCL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
  • Cohort 3: histologically confirmed CLL/SLL, failure or intolerance to at least 1 prior treatment including BTK inhibitor;
  • Cohort 4: histologically confirmed CLL/SLL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
  • Cohort 5: histologically confirmed other B-NHL, failure or intolerance to at least 1 prior treatment including BTK inhibitor;
  • Cohort 6: histologically confirmed other B-NHL, failure or intolerance to at least 1 prior standard of care (BTK inhibitors naive);
  • In addition to CLL and WM, subjects must have at least one radiographically measurable lesion
  • ECOG score 0-2;
  • Male or female patients of childbearing potential must agree to use effective methods of contraception

Who cannot join

  • Primary central nervous system lymphoma or lymphoma involving the central nervous system;
  • Serological status reflects active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
  • HIV infection;
  • Abnormalities in hematology lab results
  • Cardiac, hepatic, renal, and coagulation abnormalities
  • Concomitant clinically significant systemic active infection uncontrollable after appropriate antibiotics or other treatment;
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  • Expected survival of no more than 24 weeks as judged by the investigator;
  • Major surgery within 4 weeks prior to the first dose of study drug
  • Required or received anticoagulant therapy (warfarin, or equivalent vitamin K antagonist, or direct thrombin inhibitor, or factor Xa inhibitor, etc.) within 7 days prior to the first dose of study treatment;
  • Had undergone cell transplantation or chimeric antigen receptor T cell (CAR-T) therapy within 60 days prior to enrollment
  • Combined with uncontrolled active immune cytopenia
  • Previous treatment with non-covalently binding BTK inhibitors (e.g. LOXO-305, MK-1026, etc.);
  • Pregnant (positive pregnancy test at screening) or lactating female patients;
  • QTcF > 450 msec in male patients or QTcF > 470 msec in female patients or other significant ECG abnormalities as judged by the investigator;
  • Toxicities due to prior antilymphoma therapy have not stabilized and have not recovered to ≤ Grade 1 (except for clinically insignificant toxicities such as alopecia, etc.);
  • History of other malignancies within 5 years prior to enrollment, special cases must be discussed with the medical monitor;
  • Prior systemic anti-tumor therapy or investigational therapy received less than 4 weeks or 5 half-lives (whichever is shorter) from the start of the planned study treatment;
  • Use of strong CYP3A inhibitors or inducers and proton pump inhibitors within 1 week or 5 half-lives (whichever is shorter) before administration of the first study drug;
  • History of acute myocardial infarction, unstable angina, stroke, intracranial hemorrhage or transient ischemic attack within 6 months prior to enrollment; New York Heart Association (NYHA) grade 3 and 4 congestive heart failure;
  • Live viral vaccination within 28 days prior to the first dose of study drug;
  • Unable to take oral drugs, or have severe gastrointestinal diseases that investigator believes that it may affect the absorption of the study drug;
  • Insufficient compliance of patients participating in this clinical study as judged by the investigator;
  • Any other disease or condition in the judgment of the investigator that the patient is not suitable for the study drug, or will affect the interpretation of the study results

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou

  • The First Affiliated School of Guangxi Medical University

    Nanning

  • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

    Shanghai

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

  • Henan Oncology Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin's Lymphoma (NHL)

This is a Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin's Lymphoma (NHL)

Read the detailed description

The study is divided into 2 phases. Phase1 dose escalation part will enroll 17-36 patients to evaluate safety and tolerance of BN102 in patients with relapsed/refractory (R/R) CLL/SLL and B-NHL to determine maximum tolerated dose and recommended phase2 dose(RP2D).

Phase 2 expansion part will enroll 72-138 patients and be conducted at the selected dose level to further evaluate the safety and tolerability of BN102,as well as preliminary efficacy in specific subtypes of lymphoma. Patients will be allocated into 6 lymphoma subgroup cohorts depends on whether their previous treatment with or without BTK inhibitors.

  • Cohort 1: patients with mantle cell lymphoma (MCL) previously treated with BTK inhibitors
  • Cohort 2: patients with MCL who have not previously received a BTK inhibitor
  • Cohort 3: patients with CLL/SLL who have received prior BTK inhibitors
  • Cohort 4: patients with CLL/SLL who have not received prior BTK inhibitors
  • Cohort 5: other B-NHL patients who have received prior BTK inhibitors
  • Cohort 6: other B-NHL patients who have not received prior BTK inhibitors

Patients will receive orally administrated BN102 twice daily under fasting status. Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity, death, ICF withdraw ect. Subjects may receive study drug in the inpatient or outpatient setting.

Conditions
CLL/SLL, NHL
Being tested
BN102
Keywords
relapsed/refractory or intolerable
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BN102Drug

    Also called AS-1763

    oral tablets: BN102, BID

Study groups in NCT05365100
Study groupRoleWhat they receive
Phase1dose escalationExperimentalPhase1 Dose Escalation Multiple dose levels of BN102 to be evaluated; determination of MTD/Phase 2 recommended dose(RP2D)
Receives: Drug: BN102
Phase2 expansion in R/R MCL with BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patients previous treatment should with BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102
Phase2 expansion in R/R MCL without BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patients previous treatment should without BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102
Phase2 expansion in R/R CLL/SLL with BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patients previous treatment should with BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102
Phase2 Expansion in R/R CLL/SLL without BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patents previous treatment should without BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102
Phase2 Expansion in other R/R B-NHL with BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patents previous treatment should with BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102
Phase2 Expansion in other R/R B-NHL without BTK inhibitor treatment historyExperimentalpatients must have received at least one systemic treatment and failed or relapsed, patents previous treatment should without BTK inhibitor, approximate 12-23 patients this group
Receives: Drug: BN102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events and Clinical Laboratory Abnormalities

    Phase1

    Measured: 2 year

  2. To assess the preliminary anti-tumor activity of BN102 based on Overall response rate(ORR) assessed by the Investigator

    Phase2

    Measured: 3 years

Secondary outcomes (13)

  1. Overall response rate(ORR) as assessed by the Investigator

    Phase1

    Measured: 3 years

  2. Time to response(TTR) as assessed by the Investigator

    Phase1/2

    Measured: 3 years

  3. Duration of response(DoR) as assessed by the Investigator

    Phase1/2

    Measured: 3 years

  4. Progression-free survival(PFS) as assessed by the Investigator

    Phase1/2

    Measured: 3 years

  5. Overall Survival(OS) as assessed by the Investigator

    Phase1/2

    Measured: 3 years

  6. To characterized Maximum Plasma Concentration [Cmax] of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  7. To characterized Peak time(Tmax) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  8. To characterized Clearance half-life (T1/2) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  9. To characterized Area under the blood concentration-time curve (AUC0-t) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  10. To characterized Clearance rate (CL/F) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  11. To characterized apparent volume of distribution (Vd/F) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  12. To characterized mean residence time (MRT) of BN102 by collecting and evaluating the serum at the protocol specified time points.

    Phase1/2

    Measured: at the end of cycle1(each cycle is28days) and Cycle2 Day1

  13. Number of Participants with Adverse Events and Clinical Laboratory Abnormalities

    Phase2

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study startJul 2022 (estimated)
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Why it stopped: Due to company decision

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365100
Sponsor's protocol ID
BN102-101
Status last verified
Mar 2023
First submitted
26 Apr 2022
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BN102 in people with CLL/SLL and NHL, run by BioNova Pharmaceuticals (Shanghai) LTD. at 6 sites 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 14 inclusion and 23 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: withdrawn, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events and Clinical Laboratory Abnormalities (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365100.

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 24 Mar 2023.

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