Trial · NCT02933320
BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
NCT02933320, Phase 1, Phase 2, Completed, Cancer Research UK; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia. Trials, record NCT02933320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02933320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
- NCT number
- NCT02933320
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Cancer Research UK
- Conditions
- B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia
- Interventions
- BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase, BI-1206 single agent expansion phase, Combination of BI-1206 with rituximab expansion phase
- First posted
- 2016-10-14
- Last updated
- 2021-07-08
- Other registries' IDs
- eudract:2015-004999-29
- Results first posted
- 2021-07-08
- Limitations and caveats
The trial was terminated early by the Sponsor based on a strategic decision and not a safety related decision. At the time of trial termination, 14 patients had received BI-1206. No patients received rituximab. As a result of the early termination Part B of the trial did not open.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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. | To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients. |
| Primary | Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody. | 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. | Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies. |
| Secondary | Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Maximum observed serum concentration after intravenous BI-1206 administration |
| Secondary | Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration. |
| Secondary | Measurement of PK Parameter Half-life (T1/2) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | BI-1206 half-life after intravenous administration |
| Secondary | Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Total body clearance after intravenous BI-1206 administration |
| Secondary | Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Volume of distribution after administration of BI-1206 |
| Secondary | Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA | Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit. | Patients with true ADA response |
| Secondary | Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry. | During induction phase (up to 8 weeks). | Number of patients with B-lymphocyte depletion during BI-1206 treatment period. |
| Secondary | Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008). | Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study. | To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 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. | Safety population | Number of events | NUMBER |
| PRIMARY | Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody. | 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. | Safety population | BI-1206 MAD (mg) | NUMBER |
| SECONDARY | Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | ng/mL | MEDIAN |
| SECONDARY | Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | h*ng/mL | MEDIAN |
| SECONDARY | Measurement of PK Parameter Half-life (T1/2) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | h | MEDIAN |
| SECONDARY | Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | mL/h/kg | MEDIAN |
| SECONDARY | Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort. | mL/kg | MEDIAN |
| SECONDARY | Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA | Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit. | Anti-drug antibody response population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry. | During induction phase (up to 8 weeks). | B-lymphocyte depletion population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008). | Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study. | Response population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | All AEs | 282 | Number of events | |
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. | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | All AEs | 13 | Number of events | |
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. | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | Related AEs | 214 | Number of events | |
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. | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | Related AEs | 12 | Number of events | |
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. | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | DLT - ALT | 1 | Number of events | |
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. | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | DLT - ALT | 0 | Number of events | |
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. | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | DLT - AST | 1 | Number of events | |
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. | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | DLT - AST | 0 | Number of events | |
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. | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | DLT - infusion related reaction | 0 | Number of events | |
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. | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | DLT - infusion related reaction | 1 | Number of events |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 13 | |
| Overall Study | STARTED | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | |
| Overall Study | STARTED | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | |
| Overall Study | STARTED | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | |
| Overall Study | COMPLETED | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 13 | |
| Overall Study | COMPLETED | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | |
| Overall Study | COMPLETED | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | |
| Overall Study | COMPLETED | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | |
| Overall Study | NOT COMPLETED | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 0 | |
| Overall Study | NOT COMPLETED | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 4 | 13 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | ||
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 4 | 13 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 0 | 1 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | ||
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | ||
| other | Tachycardia | Cardiac disorders | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 4 | 13 | 5 |
| other | Tachycardia | Cardiac disorders | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | 1 | 1 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 1 | 13 |
| Total, all-cause mortality | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 0 | 1 |
| Total, all-cause mortality | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | 0 |
| Total, all-cause mortality | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | 0 |
| Total, other adverse events | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 13 | 13 |
| Total, other adverse events | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | 1 |
| Total, other adverse events | Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 | 0 |
| Total, other adverse events | Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 | 0 |
| Total, serious adverse events | Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 10 | 13 |
| Total, serious adverse events | Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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