Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab With or Without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab
- Conditions
- Indolent B-Cell Non-Hodgkin LymphomaMedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512972-36-00
- Lead Sponsor
- BioInvent International AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
Are = 18 years of age by initiation of study treatment., Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2., Have CD20+ malignancy as demonstrated by IHC or flow cytometry prior to first dose of BI-1206. Analysis must have been performed on the most recent biopsy obtained and must be after anti-CD20 therapy., Have hematological and biochemical indices within prespecified ranges, including hemoglobin (=9.0 g/dL, red cell support is permissible); absolute neutrophil count (ANC) (=1.0 × 109/L, or >0.5 × 109/L if due to lymphoma; granulocyte-colony stimulating factor support is not permissible at screening); and platelet count (=100 × 109/L). These measurements must be performed within 1 week and assessed by the Investigator before their first dose of BI-1206., Provide written (signed and dated) informed consent., Are capable of cooperating with treatment and follow-up., Have B-cell NHL proven by histology, with histological subtypes limited to FL (except FL3B), MCL and MZL., Have measurable nodal disease, defined as the presence of =1 nodal lesion that measures =1.5 cm in a single dimension as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI)., Are willing to undergo lymph node biopsies or biopsies of other involved tissue (besides bone marrow). However, if a biopsy is not technically feasible, the sample can be omitted. If viable frozen tissue (not formalin-fixed) from a previous standard of care biopsy in the previous 8 weeks prior to consent is available, a new biopsy at screening is not required., Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists, the investigator judges available standard therapy as not being appropriate for the subject, or is declined by the subject. Rituximab refractory disease is defined as: • Lack of CR or PR during rituximab-containing treatment comprising =2 doses of =375 mg/m2, or • Occurrence of progressive disease up to one year after completion of a regimen of rituximab-containing therapy comprising =2 doses of =375 mg/m2, or • Occurrence of progressive disease during rituximab maintenance therapy or within 6 months of completion of rituximab maintenance therapy., Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen., Have a life expectancy of at least 12 weeks on the day of the first infusion of BI-1206.
Have had an allogenic bone marrow or stem cell transplant within 12 months prior to the first dose of BI-1206., Have ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator should not exclude the subject., Have the ability to become pregnant (or pregnant or lactating/breastfeeding). However, those female subjects who have a negative serum pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial and for 12 months after last dose of BI 1206 are considered eligible. Highly effective methods of birth control include: • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation • Progestogen-only hormonal contraception associated with inhibition of ovulation • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence, Are male subjects with partners of childbearing potential (unless they agree not to father children by using one form of highly effective contraception (condom plus spermicide gel) during the trial and for 12 months after completing treatment). Men with pregnant or lactating partners should be advised to use barrier method contraception (condom plus spermicidal gel) to prevent exposure to the fetus or neonate., Have had major surgery from which the subject has not yet recovered., Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals., Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)., Have an active, known or suspected autoimmune disease. However, subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia not requiring systemic treatment), or conditions not expected to recur in the absence of an external trigger will be permitted to participate., Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), history of clinically significant cardiac ischemia or cardiac arrhythmia in the past 6 months., Have ongoing alcohol or drug addiction, as judged by the Investigator., Have any other condition which in the Investigator's opinion would not make the subject a good candidate for the clinical trial., Have presence of active chronic graft versus host disease of any grade/severity., Are participating or plan to participate in another interventional clinical study, while taking part in this Phase 1/2a study of BI-1206. Participation in an observational non-interventional study is acceptable., Have current malignancies of other types, with the exception of: • adequately treated cone-biopsied in situ carcinoma of the cervix uteri • basal or squamous cell carcinoma of the skin • asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of study therapy. Cancer survivors, who have undergone potentially curative therapy, have no evidence of that disease for = 3 years and are deemed at negligible risk for recurrence, are also eligible for the trial., Have current leptomeningeal lymphoma or compr
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method