Trial record 1 of 1 for:
17-BI-1206-02
A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
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| ClinicalTrials.gov Identifier: NCT03571568 |
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Recruitment Status :
Recruiting
First Posted : June 27, 2018
Last Update Posted : January 30, 2024
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Sponsor:
BioInvent International AB
Information provided by (Responsible Party):
BioInvent International AB
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Brief Summary:
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Indolent B-Cell Non-Hodgkin Lymphoma | Biological: BI-1206 | Phase 1 Phase 2 |
This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL, and MCL.
The trial consists of 2 main parts:
- Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV).
- Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in combination with rituximab (administered IV).
Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle of induction therapy with BI-1206 in combination with rituximab.
Subjects who show clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206 ( using the same dose and route of administration as induction therapy) and rituximab once every 8 weeks (relative to previous maintenance dose) for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206 (whichever occurs first).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 98 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximab |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcYRIIB), in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab |
| Actual Study Start Date : | May 16, 2018 |
| Estimated Primary Completion Date : | September 22, 2025 |
| Estimated Study Completion Date : | September 22, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information
available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: BI-1206 IV
BI-1206 IV Standard 3+3 Dose-Escalation Design
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Biological: BI-1206
375 mg/m2, as per SmPC
Other Name: Rituximab |
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Experimental: BI-1206 SC
BI-1206 SC Adaptive Dose Escalation Design (Bayesian logistic regression model (BLRM)
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Biological: BI-1206
375 mg/m2, as per SmPC
Other Name: Rituximab |
Primary Outcome Measures :
- Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab [ Time Frame: During the 28-day treatment period on induction therapy ]Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL),subtypes follicular lymphoma (FL)(except FLgrade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).
- Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT) [ Time Frame: During the 28-day treatment period on induction therapy ]Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.
Secondary Outcome Measures :
- Evaluation of PK parameters for BI-1206. [ Time Frame: Up to 1 year ]Study the PK profile of BI-1206 when administered IV or SC in combination with rituximab in subjects with relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL and MCL.
- Evaluation of PK parameters for rituximab during the BI-1206 treatment period. [ Time Frame: Up to 1 year ]Study the PK profile of rituximab when administered in combination with BI-1206 (IV or SC).
- Evaluation of ADA response to BI 1206. [ Time Frame: Up to 1 year ]Assess the immunogenicity of BI-1206 when administered IV or SC in combination with rituximab.
- Measurement of B cell depletion. [ Time Frame: Up to 1 year ]Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab on the depletion of B-cells.
- Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014). [ Time Frame: Up to 1 year ]Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.
- CD32b protein expression levels [ Time Frame: Up to 1 year ]Investigate CD32b protein expression levels; evaluate any potential correlation with clinical responses.
Other Outcome Measures:
- Measurement of PROs using the PRO-CTCAE questionnaire. [ Time Frame: Up to 1 year ]Evaluate patient-reported outcomes (PROs)in subjects receiving BI-1206
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are ≥ 18 years of age by initiation of study treatment.
- Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL).
- Have measurable nodal disease
- Are willing to undergo lymph node biopsies or biopsies of other involved tissue
- Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists.
- 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have CD20+ malignancy
- Have hematological and biochemical indices within prespecified ranges
Exclusion Criteria:
- Have had an allogenic bone marrow or stem cell transplant within 12 months
- Have presence of active chronic graft versus host disease
- Have current leptomeningeal lymphoma or compromise of the central nervous system.
- Have transformed lymphoma from a pre-existing indolent lymphoma.
- Have Waldenstrom's Macroglobulinemia or FL3B,
- Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.
- Have known or suspected hypersensitivity to rituximab or BI-1206.
- 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
- Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks
- Immunotherapy within 8 weeks
- Have ongoing toxic manifestations of previous treatments.
- Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).
- 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.
- Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]),
- Have current malignancies of other types
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571568
Contacts
| Contact: Erika Bågeman | +46706126618 | erika.bageman@bioinvent.com | |
| Contact: Andres McAllister, MD, PhD | andres.mcallister@bioinvent.com |
Locations
Show 22 study locations
Sponsors and Collaborators
BioInvent International AB
Investigators
| Principal Investigator: | Mats Jerkeman, MD PhD | Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden |
| Responsible Party: | BioInvent International AB |
| ClinicalTrials.gov Identifier: | NCT03571568 |
| Other Study ID Numbers: |
17-BI-1206-02 |
| First Posted: | June 27, 2018 Key Record Dates |
| Last Update Posted: | January 30, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All information concerning the product as well as any matter concerning the operation of the Sponsor, such as clinical indications for the drug, its formula, methods of manufacture and other scientific data relating to it, that have been provided by the Sponsor and are unpublished, are confidential and must remain the sole property of the Sponsor. The Investigator will agree to use the information only for the purposes of carrying out this study and for no other purpose unless prior written permission from the Sponsor is obtained. |
| Supporting Materials: |
Study Protocol Clinical Study Report (CSR) |
| Time Frame: | Within one year from end of study |
| Access Criteria: | Paper copy of CSR |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |