A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
BioInvent International AB
Study ID
NCT03571568
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Indolent B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI-1206 — BIOLOGICAL
    BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion
  • Rituximab — BIOLOGICAL
    Rituximab 375 mg/m2, as per SmPC
  • Acalabrutinib — BIOLOGICAL
    Acalabrutinib 100 mg orally as per SmPC

Study Details

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

Key Dates

Start date
May 16, 2018
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BI-1206 IV Dose Escalation
    Standard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab
  • Experimental: BI-1206 SC Dose Escalation
    Adaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab
  • Experimental: Phase 2a IV Dose expansion
    BI-1206 IV in Combination with Rituximab
  • Experimental: Phase 2a SC Signal seeking
    SC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
  • Experimental: Phase 2a IV Signal Seeking
    IV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib

Primary Outcome Measure

Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib [ Time Frame: During the 28-day treatment period on induction therapy ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405LouisvilleKentucky40207
Don Stevens, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GANorton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405· Louisville, KY

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