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

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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