Authorised Phase I and Phase II (Integrated)- Other Indolent B-Cell Non-Hodgkin Lymphoma

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

EU CTIS ID: 2024-512972-36-00

What this study is testing

Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory Bcell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL) (except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma(MCL). Phase 1 Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 administered via IV infusion or SC injection in combination with rituximab. Phase 2a, BI-1206 in Combination with Rituximab and Acalabrutinib: Selection of recommended dose of BI-1206 in combination with rituximab and acalabrutinib.

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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.

You likely can't join if

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.

See the full eligibility criteria

Who can join

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.

What rules you out

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 compromise of the central nervous system.
Have transformed lymphoma from a pre-existing indolent lymphoma. Subjects with a previous history of transformation, but on this disease episode have a biopsy proven indolent recurrence, may be included. Subjects with proven or suspected Richter transformation are not eligible.
Have Waldenstrom's Macroglobulinemia or FL3B, due to the high risk of transformation while on study.
Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study other than as premedication. During the screening period, doses of up to 20 mg/day may be given but the dose must be reduced to 10 mg/day within 7 days prior the first dose of study drug. Inhaled or intranasal steroids are permissible.
Have known or suspected hypersensitivity to rituximab or BI-1206. Previous isolated IRRs are not to be considered a reason for exclusion.
Have cardiac or renal amyloid light-chain amyloidosis.
Have received any of the following: • Chemotherapy or small molecule products with 2 weeks of first dose of BI- 1206 and/or • Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks of first dose of BI-1206 and/or • Immunotherapy within 8 weeks prior to the first dose of BI-1206. Subjects receiving BI-1206 with rituximab and acalabrutinib: previous lines of treatment containing BTK inhibitors.

The study team makes the final eligibility decision.

Where it's taking place

Brazil
United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.