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B-cell LymphomaPhase 1/2NCT05611853

Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

A Phase 1/2 study testing BN301 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, run by BioNova Pharmaceuticals (Shanghai) LTD. at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase 1/2 trial to study the safety, pharmacokinetics and preliminary efficacy of BN301 given intravenously every 3 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BN301
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
6 sitesChina
Study dates
25 Nov 2022to 25 Dec 2023
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

  • Have been fully informed about the study and have voluntarily signed the ICF;
  • Age ≥ 18 years;
  • Histologically confirmed as B-cell NHL (pathology report), including DLBCL, FL, MZL, and MCL, etc., and the disease requires further treatment;
  • Have relapsed/refractory disease or intolerance to prior therapy after ≥ 2 prior lines of therapy including anti-CD20 antibody-containing chemotherapy regimens (e.g., R-CHOP, etc.) (see Section 3.1 for specific definitions);
  • At least 1 radiographically measurable lesion (≥ 1 lymph node lesion with longest diameter of > 1.5 cm, and/or extranodal lesion with longest diameter of >1.0 cm, as assessed by computed tomography [CT]), and no prior radiotherapy on the lesion (evidence of unequivocal progression is required if the lesion has received prior radiotherapy);
  • ECOG score 0-2;
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  • Adequate hematological status (supportive care such as growth factor, platelet transfusion or blood transfusion or correction with drugs are not allowed within 5 days prior to screening):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelets ≥ 75 × 109/L Hemoglobin ≥ 9 g/dL Note: In Phase 2, if the investigator believes that the above values below the lower limit of the protocol are due to bone marrow involvement by lymphoma, the patient could be enrolled after consultation between investigator and the Sponsor and obtaining written consent from the Sponsor;
  • Adequate hepatic, renal, and cardiac functions, defined as:
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  • 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN, total bilirubin ≤ 3 × ULN for patients with Gilbert's disease; Creatinine clearance ≥ 50 mL/min as estimated by the Cockcroft-Gault f formula (if < 50 mL/min, e.g., creatinine ≤ 130 μmol/L is also allowed); Left ventricular ejection fraction ≥ 45%; Note: In Phase 2, the criteria for ALT or AST may be relaxed to ≤ 5 × ULN if the investigator assesses that the increase in ALT or AST is due to liver invasion by lymphoma;
  • Male or female patients of childbearing potential must agree to use effective methods of contraception, such as double barrier methods of contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study and within 90 days after the last dose of study drug. Postmenopausal women (> 45 years of age and menopause for more than 1 year) and surgically sterilized women are not subject to this condition.

Who cannot join

  • Chronic lymphocytic leukemia and T-cell malignancies;
  • Primary central nervous system lymphoma or lymphoma involving the central nervous system;
  • Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Subjects with occult or pre-hepatitis B infection (defined as HBcAb positive, HBsAg negative) could be enrolled if HBV DNA test result is negative, and subjects with serologically positive HCV antibody, such as negative HCV RNA test result, could also be enrolled;
  • Known human immunodeficiency virus (HIV) infection;
  • Concomitant clinically significant active infections requiring systemic treatment, including but not limited to chronic kidney infection, chronic chest infection with bronchiectasis and tuberculosis, etc.;
  • Expected survival of no more than 24 weeks as judged by the investigator;
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  • Previous solid organ transplant; autologous hematopoietic stem cell transplant, allogeneic hematopoietic stem cell transplant, or chimeric antigen receptor T-cell (CAR-T) therapy within 60 days prior to enrollment, or had the following conditions:
  • Active graft versus host disease (GVHD);
  • Cytopenia due to unrecovered hematopoiesis after transplantation;
  • Anti-cytokine therapy (e.g., tocilizumab, glucocorticoids) is still required due to CAR-T cell treatment toxicity, or neurological toxicity is > Grade 1 after CAR-T cell therapy;
  • Continuous use of immunosuppressive therapy;
  • 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 anti-lymphoma therapy have not stabilized and have not recovered to ≤ Grade 1 (except for clinically insignificant toxicities such as alopecia, etc.);
  • Other malignancies in the past 5 years, with the exception of radically treated basal cell carcinoma of skin, breast cancer in situ and cervix carcinoma in situ;
  • The time from prior systemic anti-tumor therapy or investigational therapy to the start of the planned study treatment is less than 4 weeks or 5 half-lives (whichever is shorter);
  • History of acute myocardial infarction, unstable angina pectoris, 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;
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment (Phase 1 dose escalation part only);
  • Grade ≥ 2 sensory or motor neuropathy;
  • Known severe chronic obstructive pulmonary disease or asthma, defined as forced expiratory volume in one second (FEV1) < 60% of expected value;
  • Prior therapies targeting CD74;
  • Insufficient compliance of patients participating in this clinical study as judged by the investigator;
  • Any other disease, metabolic abnormality, physical examination abnormality, or clinically significant laboratory abnormality, for which in the investigator's judgment, there is reason to suspect that the patient has a disease or condition that is not suitable for the study drug, or will affect the interpretation of the study results, or place the patient at high risk (e.g., the suitability of patients for inclusion in the study will be determined by the investigator if they have recovered from COVID-19)；
  • Live viral vaccination within 28 days prior to the first dose of study drug.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The first affiliated hospital, Zhejiang Unviersity school of medicine

    Hangzhou

  • 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 BN301，An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma

Phase 1/2 trial to study the safety, pharmacokinetics and preliminary efficacy of BN301 given intravenously every 3 weeks.

Read the detailed description

This is a multicenter, open-label Phase 1/2 clinical study to evaluate BN301 administered intravenously in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy. This study includes two parts: a Phase 1 dose escalation part and a Phase 2 dose expansion part. In Phase 1 and Phase 2, BN301 will be administered intravenously on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent, loss to follow-up, death, or other conditions in which patients are not suitable for study treatment, whichever occurs first.

Laboratory tests will be performed weekly in Cycles 1-4 and every 3 weeks from Cycle 5 onwards (see Study Flow Chart). PK sample analysis will be performed on Days 1, 2, and 8 of the first two treatment cycles, Day 1 of the third treatment cycle, and at specified time points at the end of treatment (see Attachment 1). Additional clinical assessments and laboratory tests may be performed at discretion of the investigator as clinically indicated.

Being tested
BN301
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

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

  • BN301Drug

    Also called STRO-001

    BN301 will be administered intravenously on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent, loss to follow-up, death, or other conditions in which patients are not suitable for study treatment, whichever occurs first. Since this is the first time BN301 will be used in Chinese patients, it is planned to enroll 1 subject at the first dose level of 3.5 mg/kg.

Study groups in NCT05611853
Study groupRoleWhat they receive
3.5mg/kgExperimentalWill be administered by intravenous infusion every 3 weeks on D1
Receives: Drug: BN301
4.2mg/kgExperimentalWill be administered by intravenous infusion every 3 weeks on D1
Receives: Drug: BN301
5.0mg/kgExperimentalWill be administered by intravenous infusion every 3 weeks on D1
Receives: Drug: BN301

What is being measured

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

  1. Incidence of Treatment-Related Adverse Events as Assessed by CTCAE v4.0.3

    Safety and tolerability

    Measured: 12 months

  2. Objective Response Rate of participants as assessed by the Lugano 2014 criteria.

    Efficacy

    Measured: 2 years

Secondary outcomes (5)

  1. Maximum concentration (Cmax)

    Cmax of BN301 in plasma of each subject

    Measured: 12 months

  2. Time to maximum concentration (Tmax)

    Tmax of BN301 in plasma of each subject

    Measured: 12 months

  3. Elimination half-life (t1/2)

    Elimination half-life (t1/2) of BN301 in plasma of each subject

    Measured: 12 months

  4. Area under the plasma concentration-time curve (AUC0-t)

    Area under the plasma concentration-time curve (AUC0-t) of BN301 in plasma of each subject

    Measured: 12 months

  5. CD74 expression

    The analysis of correlation between CD74 expression and BN301 efficacy

    Measured: 12 months

Timeline

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

  1. First posted10 Nov 2022
  2. Study start25 Nov 2022
  3. Primary completion25 Dec 2023
  4. Study completion25 Dec 2023

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05611853
Sponsor's protocol ID
BN301-101
Status last verified
Feb 2024
First submitted
26 Oct 2022
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BN301 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, 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 12 inclusion and 24 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: stopped early, as of the sponsor's last update on 21 Feb 2024. 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 stopped early (reason given: Due to company decision). Results are not available in the source record.

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?

Incidence of Treatment-Related Adverse Events as Assessed by CTCAE v4.0.3 (time frame: 12 months). 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 NCT05611853.

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 21 Feb 2024.

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