Trial Outcomes & Findings for BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia (NCT NCT02933320)

NCT ID: NCT02933320

Last Updated: 2021-07-08

Results Overview

To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: 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.
• Results posted on: 2021-07-08

Participant Flow

Trial participants were enrolled at four trial sites between 27 October 2016 and 09 December 2019.

Participant milestones

Measure	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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Overall Study STARTED	13	1	0	0
Overall Study COMPLETED	13	1	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=1 Participants	—	—	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=13 Participants	1 Participants n=1 Participants	—	—	6 Participants n=14 Participants
Age, Categorical >=65 years	8 Participants n=13 Participants	0 Participants n=1 Participants	—	—	8 Participants n=14 Participants
Sex: Female, Male Female	5 Participants n=13 Participants	1 Participants n=1 Participants	—	—	6 Participants n=14 Participants
Sex: Female, Male Male	8 Participants n=13 Participants	0 Participants n=1 Participants	—	—	8 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	13 participants n=13 Participants	1 participants n=1 Participants	—	—	14 participants n=14 Participants

PRIMARY outcome

Timeframe: 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.

Population: Safety population

To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
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. DLT - infusion related reaction	0 Number of events	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. All AEs	282 Number of events	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. Related AEs	214 Number of events	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. DLT - ALT	1 Number of events	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. DLT - AST	1 Number of events	0 Number of events	—	—

PRIMARY outcome

Timeframe: 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.

Population: Safety population

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.

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
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.	100 BI-1206 MAD (mg)	NA BI-1206 MAD (mg) 50 mg BI-1206 given but not rituximab	—	—

SECONDARY outcome

Timeframe: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

Population: 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.

Maximum observed serum concentration after intravenous BI-1206 administration

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 0.4 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)	6075 ng/mL Interval 31.2 to 13100.0	—	—	—
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 1	15600 ng/mL Interval 6990.0 to 19300.0	—	—	—
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 4	12700 ng/mL Interval 8850.0 to 22500.0	—	—	—

SECONDARY outcome

Timeframe: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

Population: 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.

Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration.

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 0.4 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)	76100 h*ng/mL Interval 9.1 to 384000.0	—	—	—
Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 1	462000 h*ng/mL Interval 129000.0 to 594000.0	—	—	—
Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 4	193000 h*ng/mL Interval 168000.0 to 733000.0	—	—	—

SECONDARY outcome

Timeframe: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

Population: 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.

BI-1206 half-life after intravenous administration

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of PK Parameter Half-life (T1/2) for BI-1206 0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)	NA h Half-life could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.	—	—	—
Measurement of PK Parameter Half-life (T1/2) for BI-1206 10 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)	17.3 h Interval 9.3 to 18.9	—	—	—
Measurement of PK Parameter Half-life (T1/2) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 1	16 h Interval 11.5 to 21.6	—	—	—
Measurement of PK Parameter Half-life (T1/2) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 4	12.1 h Interval 10.8 to 46.6	—	—	—

SECONDARY outcome

Timeframe: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

Population: 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.

Total body clearance after intravenous BI-1206 administration

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)	NA mL/h/kg CL could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.	—	—	—
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 10 - 50 mg BI-1206 (Cohort 1 intra patient dose escalation)	6.34 mL/h/kg Interval 2.45 to 10.8	—	—	—
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 1	3.32 mL/h/kg Interval 1.82 to 9.63	—	—	—
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 4	7.44 mL/h/kg Interval 6.61 to 8.64	—	—	—

SECONDARY outcome

Timeframe: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

Population: 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.

Volume of distribution after administration of BI-1206

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)	NA mL/kg Vss could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.	—	—	—
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 10 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)	84.2 mL/kg Interval 60.6 to 208.0	—	—	—
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 1	81.0 mL/kg Interval 50.5 to 182.0	—	—	—
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 100 mg BI-1206 (Cohort 2) Dose 4	126 mL/kg Interval 124.0 to 143.0	—	—	—

SECONDARY outcome

Timeframe: Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit.

Population: Anti-drug antibody response population

Patients with true ADA response

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=12 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: During induction phase (up to 8 weeks).

Population: B-lymphocyte depletion population

Number of patients with B-lymphocyte depletion during BI-1206 treatment period.

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=11 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry.	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study.

Population: Response population

To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
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). Stable disease	3 Participants	0 Participants	—	—
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). Progressive disease	7 Participants	0 Participants	—	—
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). Not evaluable	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From first BI-1206 administration up to 12 months

Population: Progression free survival population

To measure the time to disease progression and twelve month survival

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 Participants 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients Progression free & alive	2 Participants	0 Participants	—	—
Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients Progressed, died or unknown	11 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored.

Population: Overall survival population

To measure the time to disease progression and twelve month survival

Outcome measures

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=5 Participants 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients	152.2 Days Interval 38.0 to 360.0	—	—	—

Adverse Events

Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase

Serious events: 10 serious events

Other events: 13 other events

Deaths: 1 deaths

Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Arm1: BI-1206 Single Agent Expansion Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 participants at risk 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 participants at risk 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Non-cardiac chest pain	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Abdominal abscess	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Lower respiratory tract infection	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Metapneumovirus infection	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Neutropenic sepsis	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Pneumonia	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Injury, poisoning and procedural complications Infusion related reaction	38.5% 5/13 • Number of events 11 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Hyperkalaemia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Hyperuricaemia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Pleural effusion	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.

Other adverse events

Measure	Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase n=13 participants at risk 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). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.	Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase n=1 participants at risk 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.	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 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.	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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
Blood and lymphatic system disorders Anaemia	30.8% 4/13 • Number of events 5 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Blood and lymphatic system disorders Thrombocytopenia	30.8% 4/13 • Number of events 5 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Cardiac disorders Tachycardia	30.8% 4/13 • Number of events 5 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Eye disorders Blepharitis	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Eye disorders Cataract	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Eye disorders Normal tension glaucoma	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Eye disorders Periorbital oedema	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Eye disorders Vision blurred	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Constipation	23.1% 3/13 • Number of events 4 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Diarrhoea	30.8% 4/13 • Number of events 4 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Dyspepsia	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Flatulence	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Lip swelling	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Nausea	38.5% 5/13 • Number of events 6 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Chest discomfort	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Chills	46.2% 6/13 • Number of events 7 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Fatigue	61.5% 8/13 • Number of events 9 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Feeling cold	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Feeling hot	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Non-cardiac chest pain	23.1% 3/13 • Number of events 3 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Oedema peripheral	23.1% 3/13 • Number of events 3 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Pain	7.7% 1/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
General disorders Pyrexia	38.5% 5/13 • Number of events 6 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Folliculitis	15.4% 2/13 • Number of events 3 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Lower respiratory tract infection	7.7% 1/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Rhinitis	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Infections and infestations Urinary tract infection	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Injury, poisoning and procedural complications Infusion related reaction	69.2% 9/13 • Number of events 30 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Alanine aminotransferase increased	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Blood creatinine increased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Blood immunoglobulin G decreased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Body temperature increased	15.4% 2/13 • Number of events 3 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations C-reactive protein increased	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations CD4 lymphocytes decreased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Oxygen saturation decreased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Platelet count decreased	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Serum ferritin increased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Investigations Weight decreased	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Decreased appetite	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Gout	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Metabolism and nutrition disorders Hypophosphataemia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Back pain	23.1% 3/13 • Number of events 5 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Flank pain	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Nervous system disorders Dizziness	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Nervous system disorders Headache	15.4% 2/13 • Number of events 6 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Nervous system disorders Lethargy	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Nervous system disorders Paraesthesia	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Nervous system disorders Presyncope	23.1% 3/13 • Number of events 4 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Psychiatric disorders Anxiety	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Hypoxia	15.4% 2/13 • Number of events 7 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Hair texture abnormal	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Night sweats	15.4% 2/13 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Palmar erythema	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Pruritus	15.4% 2/13 • Number of events 8 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Rash maculo-papular	15.4% 2/13 • Number of events 3 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Urticaria	61.5% 8/13 • Number of events 25 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 2 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Vascular disorders Flushing	38.5% 5/13 • Number of events 12 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Vascular disorders Hot flush	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Vascular disorders Hypertension	30.8% 4/13 • Number of events 8 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Vascular disorders Hypotension	46.2% 6/13 • Number of events 11 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Vascular disorders Pallor	7.7% 1/13 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	0.00% 0/1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/13 • 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 Trial terminated before part B opened. No patients in arm B.	100.0% 1/1 • Number of events 1 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.	— 0/0 • 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 Trial terminated before part B opened. No patients in arm B.

Additional Information

Regulatory Affairs Manager

Cancer Research UK Centre for Drug Development

Phone: +44 203 4696878

Email: regulatory@cancer.org.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place