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

NCT05365100 | Withdrawn Phase 1 DMC

• 1 other identifier: BN102-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

CLL/SLL; NHL

Keywords

relapsed/refractory or intolerable

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events and Clinical Laboratory Abnormalities

  Phase1

  2 year

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

  Phase2

  3 years

Secondary Outcomes (13)

• Overall response rate(ORR) as assessed by the Investigator

  3 years

• Time to response(TTR) as assessed by the Investigator

  3 years

• Duration of response(DoR) as assessed by the Investigator

  3 years

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

  3 years

• Overall Survival(OS) as assessed by the Investigator

  3 years

Study Arms (7)

Phase1dose escalation

EXPERIMENTAL

Phase1 Dose Escalation Multiple dose levels of BN102 to be evaluated; determination of MTD/Phase 2 recommended dose(RP2D)

Drug: BN102

Phase2 expansion in R/R MCL with BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Phase2 expansion in R/R MCL without BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Phase2 expansion in R/R CLL/SLL with BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Phase2 Expansion in R/R CLL/SLL without BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Phase2 Expansion in other R/R B-NHL with BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Phase2 Expansion in other R/R B-NHL without BTK inhibitor treatment history

EXPERIMENTAL

patients 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

Drug: BN102

Interventions

BN102 DRUG

oral tablets: BN102, BID

Also known as: AS-1763

Phase1dose escalation; Phase2 Expansion in R/R CLL/SLL without BTK inhibitor treatment history; Phase2 Expansion in other R/R B-NHL with BTK inhibitor treatment history; Phase2 Expansion in other R/R B-NHL without BTK inhibitor treatment history; Phase2 expansion in R/R CLL/SLL with BTK inhibitor treatment history; Phase2 expansion in R/R MCL with BTK inhibitor treatment history; Phase2 expansion in R/R MCL without BTK inhibitor treatment history

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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;
• 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.);

Sponsors & Collaborators

• BioNova Pharmaceuticals (Shanghai) LTD.: lead

Study Sites (6)

ZhuJiang Hospital of Southern Medical University

Guangzhou, China

Location

The First Affiliated School of Guangxi Medical University

Nanning, China

Location

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

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

Wuhan, China

Location

Henan Oncology Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Weili Zhao, Prof.

  Shanghai Jiaotong University school of Medicine, Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 9, 2022
• Study Start: July 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)