B-cell LymphomaPhase 1/2NCT02933320
BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
A Phase 1/2 study testing BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase and BI-1206 single agent expansion phase in people with B-cell Lymphoma and Chronic Lymphocytic Leukaemia, run by Cancer Research UK at 5 sites in United Kingdom.
Trial summary
The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia
- What is being tested?
- BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase and BI-1206 single agent expansion phase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 27 Oct 2016to 19 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- B-cell lymphoma or CLL proven by histology or flow cytometry, relapsed or refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient. Patients should have received at least one line of conventional previous therapy which must have included a rituximab based regimen.
- CD32b positive malignancy as demonstrated centrally by immunohistochemistry or flow cytometry prior to study entry. Available tissue or blood must have been taken within six months of study entry.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-2 (Appendix 1).
- Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before their first dose of mAb (BI-1206 and/or rituximab) as part of this study.
Show all 21Show fewer
- Laboratory Test Value required
- Haemoglobin (Hb) ≥9.0 g/dL (red cell support is permissible)
- Absolute neutrophil count (ANC) ≥1.0 x 10^9/L (or >0.5 x 10^9/L if due to lymphoma), granulocyte - colony stimulating factor (G-CSF) support is not permissible at screening
- Platelet count ≥50 x 10^9/L (or ≥30 x 10^9/L if due to malignant involvement of bone marrow)
- Either:
- Serum bilirubin ≤1.5 x upper limit of normal (ULN) unless raised due to Gilbert's syndrome in which case up to 3 x ULN is permissible.
- Or:
- Alanine amino-transferase (ALT) and /or aspartate amino-transferase (AST) ≤ 2.5 x ULN unless raised due to malignant hepatic involvement in which case up to 5 x ULN is permissible
- Either:
- Calculated creatinine clearance (Cockcroft Gault) ≥30 mL/min (uncorrected value)
- Or:
- Isotope clearance measurement ≥30 mL/min (corrected)
- 18 years or over.
- B-cell lymphoma patients only: patients has at least one measurable lesion by CT scan (defined as greater than 1.5 cm in one axis) or in the case of Waldenström's macroglobulinemia, disease must be assessable by the criteria stated in Appendix 6 of the protocol.
- Patients recruited to Arm 2 in Parts A and B (combination arms) only: CD20 positive malignancy as demonstrated by immunohistochemistry or flow cytometry prior to trial entry.
Who cannot join
- Allogenic bone marrow transplant within 12 months prior to the first dose of BI-1206 or presence of chronic graft versus host disease.
- Patients with clinically active leptomeningeal or central nervous system lymphoma/leukaemia.
- Doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) are not permitted whilst on the study other than as pre-medication. During the screening period, doses of up to 20 mg per day may be given but the dose must be reduced to 10 mg/day by Cycle 1 Day 1 (or Day -7 in the CLL combination expansion).
- Known or suspected hypersensitivity to study drugs.
- Cardiac or renal amyloid light-chain (AL) amyloidosis.
- Radiotherapy, endocrine therapy, immunotherapy, chemotherapy or investigational medicinal products during the previous 4 weeks before treatment.
Show all 19Show fewer
- Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor should not exclude the patient.
- Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one highly effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence^4 for four weeks before entering the trial, during the trial and for twelve months after completing treatment are considered eligible.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of BI-1206 or rituximab on the study, throughout the trial and for twelve months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence4). Men with pregnant or lactating partners should be advised to use barrier method contraception (e.g. condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- At high medical risk because of non-malignant systemic disease including infection.
- Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Patients with an active, known or suspected autoimmune disease (not including CLL auto-immune disease). Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger will be permitted to participate.
- Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia.
- Patients for whom rituximab is contraindicated due to severe previous hypersensitivity or any other reason (Arm 2 in Parts A and B [combination arms] only).
- Ongoing infection requiring treatment with antibiotics, antifungals or antivirals. Prophylactic use of antibiotics, antifungals or antivirals would not have excluded patients.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
- Is a participant or plans to participate in another interventional clinical study, whilst taking part in this Phase I/IIa study of BI-1206. Participation in an observational study would be acceptable.
- Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Christie Hospital
Manchester, England, M20 4BX
Oxford Cancer and Haematology Centre, Churchill Hospital
Oxford, England, OX3 7LE
Derriford Hospital
Plymouth, PL6 8DH
University Hospital Southampton NHS Foundation Trust
Southampton, S016 6YD
About this study
Official title: A Cancer Research UK Phase I/IIa Clinical Trial of BI-1206; an Antibody to FcƔRIIB (CD32b), as a Single Agent and in Combination With an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Malignancy
The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.
Read the detailed description
The molecule CD32b is thought to be present on many B-cells including the malignant B-cells in some types of lymphoma and leukaemia. The study drug, BI-1206, is an anti-CD32b monoclonal antibody which attaches to CD32b on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death as well as enhancing the anti-cancer effect of other anti-CD20 antibodies such as rituximab by stopping them being absorbed by cells.
The study is a first in man clinical trial of the drug called BI-1206 on its own and then also in combination with an anti-CD20 antibody (such as rituximab) which is commonly used to treat lymphoma and some types of leukaemia.
The four main aims of this trial are to find out:
- The maximum dose of BI-1206 that can be given safely to patients (to a maximum dose of 800mg) on it's own and in combination with an anti-CD20 antibody, rituximab.
- More about the potential side effects of BI-1206 and how they can be managed.
- What happens to BI-1206 inside the body.
- The effect of BI-1206 treatment (with or without rituximab) on tumour size and survival.
Approximately 81 patients with relapsed or refractory CD32b positive B-cell lymphoma or leukaemia were planned for the trial. Approximately 34 patients to establish the maximum tolerated doses (MTDs) in Part A and a further 40 to 50 patients recruited to two expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number depending on the number of dose escalations required to reach the MTD.
- Being tested
- BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase, BI-1206 single agent expansion phase, Combination of BI-1206 with rituximab expansion phase
- Keywords
- Indolent B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia, BI-1206, CD32b
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, B-Cell, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-1206 single agent dose escalation phaseBiological
BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.
Combination of BI-1206 with rituximab escalation phaseBiological
An investigation of combination treatment of BI-1206 with rituximab.
BI-1206 single agent expansion phaseBiological
BI-1206 single agent expansion phase at the RP2D.
Combination of BI-1206 with rituximab expansion phaseBiological
BI-1206 in combination with rituximab at the RP2D.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Arm 1: BI-1206 single agent dose escalation phase | Experimental | 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). Receives: Biological: BI-1206 single agent dose escalation phase |
| Part A: Arm 2: Combination of BI-1206 with rituximab escalation phase | Experimental | 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). Receives: Biological: Combination of BI-1206 with rituximab escalation phase |
| Part B: Arm1: BI-1206 single agent expansion phase | Experimental | Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 chronic lymphocytic leukaemia (CLL) patients and six mantle cell lymphoma (MCL) patients. Receives: Biological: BI-1206 single agent expansion phase |
| Part B: Arm 2: Combination of BI-1206 with rituximab expansion phase | Experimental | 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. Receives: Biological: Combination of BI-1206 with rituximab expansion phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.
Measured: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
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.
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.
Measured: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
Secondary outcomes (10)
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206
Maximum observed serum concentration after intravenous BI-1206 administration
Measured: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206
Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration.
Measured: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Half-life (T1/2) for BI-1206
BI-1206 half-life after intravenous administration
Measured: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206
Total body clearance after intravenous BI-1206 administration
Measured: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206
Volume of distribution after administration of BI-1206
Measured: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA
Patients with true ADA response
Measured: Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit.
Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry.
Number of patients with B-lymphocyte depletion during BI-1206 treatment period.
Measured: During induction phase (up to 8 weeks).
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).
To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies
Measured: Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study.
Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients
To measure the time to disease progression and twelve month survival
Measured: From first BI-1206 administration up to 12 months
Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients
To measure the time to disease progression and twelve month survival
Measured: From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start27 Oct 2016
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Collaborators
- BioInvent International AB, Bloodwise
- Responsible party
- Sponsor
- Investigators
- Andrew Davies, Prof, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933320
- Sponsor's protocol ID
- CRUKD16001
- Other IDs
- 2015-004999-29, 2015
- Status last verified
- Jun 2021
- First submitted
- 26 Sep 2016
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cancer Research UK Phase I/IIa Clinical Trial of BI-1206; an Antibody to FcƔRIIB (CD32b), as a Single Agent and in Combination With an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Malignancy
- ClinicalTrials.gov ID
- NCT02933320
- Acronym / sponsor ID
- CRUKD16001
- Keywords
- Indolent B-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia, BI-1206, CD32b
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Collaborators
- BioInvent International AB, Bloodwise
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.
Detailed description
The molecule CD32b is thought to be present on many B-cells including the malignant B-cells in some types of lymphoma and leukaemia. The study drug, BI-1206, is an anti-CD32b monoclonal antibody which attaches to CD32b on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death as well as enhancing the anti-cancer effect of other anti-CD20 antibodies such as rituximab by stopping them being absorbed by cells.
The study is a first in man clinical trial of the drug called BI-1206 on its own and then also in combination with an anti-CD20 antibody (such as rituximab) which is commonly used to treat lymphoma and some types of leukaemia.
The four main aims of this trial are to find out:
- The maximum dose of BI-1206 that can be given safely to patients (to a maximum dose of 800mg) on it's own and in combination with an anti-CD20 antibody, rituximab.
- More about the potential side effects of BI-1206 and how they can be managed.
- What happens to BI-1206 inside the body.
- The effect of BI-1206 treatment (with or without rituximab) on tumour size and survival.
Approximately 81 patients with relapsed or refractory CD32b positive B-cell lymphoma or leukaemia were planned for the trial. Approximately 34 patients to establish the maximum tolerated doses (MTDs) in Part A and a further 40 to 50 patients recruited to two expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number depending on the number of dose escalations required to reach the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Arm 1: BI-1206 single agent dose escalation phase | Experimental | Biological: BI-1206 single agent dose escalation phaseBI-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). |
| Part A: Arm 2: Combination of BI-1206 with rituximab escalation phase | Experimental | Biological: Combination of BI-1206 with rituximab escalation phaseArm 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). |
| Part B: Arm1: BI-1206 single agent expansion phase | Experimental | Biological: BI-1206 single agent expansion phasePart B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 chronic lymphocytic leukaemia (CLL) patients and six mantle cell lymphoma (MCL) patients. |
| Part B: Arm 2: Combination of BI-1206 with rituximab expansion phase | Experimental | Biological: Combination of BI-1206 with rituximab expansion phasePart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- B-cell lymphoma or CLL proven by histology or flow cytometry, relapsed or refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient. Patients should have received at least one line of conventional previous therapy which must have included a rituximab based regimen.
- CD32b positive malignancy as demonstrated centrally by immunohistochemistry or flow cytometry prior to study entry. Available tissue or blood must have been taken within six months of study entry.
- Life expectancy of at least 12 weeks.
- World Health Organisation (WHO) performance status of 0-2 (Appendix 1).
Key exclusion criteria (19 listed)
- Allogenic bone marrow transplant within 12 months prior to the first dose of BI-1206 or presence of chronic graft versus host disease.
- Patients with clinically active leptomeningeal or central nervous system lymphoma/leukaemia.
- Doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) are not permitted whilst on the study other than as pre-medication. During the screening period, doses of up to 20 mg per day may be given but the dose must be reduced to 10 mg/day by Cycle 1 Day 1 (or Day -7 in the CLL combination expansion).
- Known or suspected hypersensitivity to study drugs.
- Cardiac or renal amyloid light-chain (AL) amyloidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI-1206 single agent dose escalation phaseBI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206. | Biological | Part A: Arm 1: BI-1206 single agent dose escalation phase |
| Combination of BI-1206 with rituximab escalation phaseAn investigation of combination treatment of BI-1206 with rituximab. | Biological | Part A: Arm 2: Combination of BI-1206 with rituximab escalation phase |
| BI-1206 single agent expansion phaseBI-1206 single agent expansion phase at the RP2D. | Biological | Part B: Arm1: BI-1206 single agent expansion phase |
| Combination of BI-1206 with rituximab expansion phaseBI-1206 in combination with rituximab at the RP2D. | Biological | Part B: Arm 2: Combination of BI-1206 with rituximab expansion phase |
Primary outcome
Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206.
Time frame: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.
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.
Time frame: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
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.
10 secondary outcomes
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206
Time frame: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206
Time frame: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Half-life (T1/2) for BI-1206
Time frame: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206
Time frame: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206
Time frame: Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA
Time frame: Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit.
Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry.
Time frame: During induction phase (up to 8 weeks).
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).
Time frame: Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study.
Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients
Time frame: From first BI-1206 administration up to 12 months
Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients
Time frame: From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for B-cell Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davies, Prof principal investigator
University of Southampton
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase and BI-1206 single agent expansion phase in people with B-cell Lymphoma and Chronic Lymphocytic Leukaemia, run by Cancer Research UK at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206. (time frame: Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.