BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia

Sponsor
Cancer Research UK
Study ID
NCT02933320
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-cell Lymphoma
  • Chronic Lymphocytic Leukaemia
  • Waldenström Macroglobulinemia

Eligibility Criteria

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

Interventions

  • BI-1206 single agent dose escalation phase — BIOLOGICAL
    BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.
  • Combination of BI-1206 with rituximab escalation phase — BIOLOGICAL
    An investigation of combination treatment of BI-1206 with rituximab.
  • BI-1206 single agent expansion phase — BIOLOGICAL
    BI-1206 single agent expansion phase at the RP2D.
  • Combination of BI-1206 with rituximab expansion phase — BIOLOGICAL
    BI-1206 in combination with rituximab at the RP2D.

Study Details

The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.

Key Dates

First listed
Oct 14, 2016
Start date
Oct 27, 2016
Status verified
Jun 2021
Primary completion
Mar 19, 2020
Completion
Mar 19, 2020

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Arm 1: BI-1206 single agent dose escalation phase
    BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).
  • Experimental: Part A: Arm 2: Combination of BI-1206 with rituximab escalation phase
    Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).
  • Experimental: Part B: Arm1: BI-1206 single agent expansion phase
    Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 chronic lymphocytic leukaemia (CLL) patients and six mantle cell lymphoma (MCL) patients.
  • Experimental: Part B: Arm 2: Combination of BI-1206 with rituximab expansion phase
    Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.

Primary Outcome Measure

Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206. [ Time Frame: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. ]

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