Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT05244070
A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1 study testing BMS-986403, Fludarabine and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, run by Bristol-Myers Squibb at 9 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
- What is being tested?
- BMS-986403, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 14 Sep 2022to 4 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
- Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)
Who cannot join
- Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study
- Systemic fungal, bacterial, viral, or other infection that is not controlled
- Active autoimmune disease requiring immunosuppressive therapy
- Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Local Institution - 0005
Birmingham, Alabama, 35249
Local Institution - 0007
Boston, Massachusetts, 02114
Local Institution - 0009
Columbus, Ohio, 43210
Local Institution - 0016
Duarte, California, 91010
Local Institution - 0026
Hackensack, New Jersey, 07601
Local Institution - 0002
Seattle, Washington, 98109-4433
Spain3 sites
Local Institution - 0024
Barcelona, 08035
Local Institution
Madrid, 28040
Local Institution
Salamanca, 37007
About this study
Official title: A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
- Being tested
- BMS-986403, Fludarabine, Cyclophosphamide
- Keywords
- BMS-986403, Relapsed and/or Refractory, Small Lymphocytic Lymphoma (CLL), Chronic Lymphocytic Leukemia (SLL)
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986403Drug
Specified dose on specified days
FludarabineDrug
Specified dose on specified days
CyclophosphamideDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986403 + Fludarabine + Cyclophosphamide | Experimental | Not described Receives: Drug: BMS-986403; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 2 years after BMS-986403 infusion
Number of participants with serious adverse events (SAEs)
Measured: Up to 2 years after BMS-986403 infusion
Number of participants with clinical laboratory abnormalities
Measured: Up to 2 years after BMS-986403 infusion
Number of participants with dose-limiting toxicity (DLT)
Measured: Up to 2 years after BMS-986403 infusion
Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
Measured: Up to 2 years after BMS-986403 infusion
Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Measured: Up to 2 years after BMS-986403 infusion
Secondary outcomes (11)
Overall response rate (ORR)
Measured: Up to 2 years after BMS-986403 infusion
Complete remission rate (CRR)
Measured: Up to 2 years after BMS-986403 infusion
Duration of response (DOR)
Measured: Up to 2 years after BMS-986403 infusion
Duration of complete remission (DOCR)
Measured: Up to 2 years after BMS-986403 infusion
Time to response (TTR)
Measured: Up to 2 years after BMS-986403 infusion
Time to CR (TTCR)
Measured: Up to 2 years after BMS-986403 infusion
Progression free survival (PFS)
Measured: Up to 2 years after BMS-986403 infusion
Overall survival (OS)
Measured: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)
Measured: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
Measured: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Area under the curve (AUC)
Measured: Up to 2 years after BMS-986403 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start14 Sep 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244070
- Sponsor's protocol ID
- CA097-001
- Other IDs
- 2021-003274-31
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- ClinicalTrials.gov ID
- NCT05244070
- Acronym / sponsor ID
- CA097-001
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
- Keywords
- BMS-986403, Relapsed and/or Refractory, Small Lymphocytic Lymphoma (CLL), Chronic Lymphocytic Leukemia (SLL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
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 study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986403 + Fludarabine + Cyclophosphamide | Experimental | Drug: BMS-986403, Drug: Fludarabine, Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
- Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)
Key exclusion criteria (5 listed)
- Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study
- Systemic fungal, bacterial, viral, or other infection that is not controlled
- Active autoimmune disease requiring immunosuppressive therapy
- Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| BMS-986403Specified dose on specified days | Drug | BMS-986403 + Fludarabine + Cyclophosphamide |
| FludarabineSpecified dose on specified days | Drug | BMS-986403 + Fludarabine + Cyclophosphamide |
| CyclophosphamideSpecified dose on specified days | Drug | BMS-986403 + Fludarabine + Cyclophosphamide |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with clinical laboratory abnormalities
Time frame: Up to 2 years after BMS-986403 infusion
Number of participants with dose-limiting toxicity (DLT)
Time frame: Up to 2 years after BMS-986403 infusion
Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period
Time frame: Up to 2 years after BMS-986403 infusion
Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Time frame: Up to 2 years after BMS-986403 infusion
11 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years after BMS-986403 infusion
Complete remission rate (CRR)
Time frame: Up to 2 years after BMS-986403 infusion
Duration of response (DOR)
Time frame: Up to 2 years after BMS-986403 infusion
Duration of complete remission (DOCR)
Time frame: Up to 2 years after BMS-986403 infusion
Time to response (TTR)
Time frame: Up to 2 years after BMS-986403 infusion
Time to CR (TTCR)
Time frame: Up to 2 years after BMS-986403 infusion
Progression free survival (PFS)
Time frame: Up to 2 years after BMS-986403 infusion
Overall survival (OS)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)
Time frame: Up to 2 years after BMS-986403 infusion
Pharmacokinetics by PCR: Area under the curve (AUC)
Time frame: Up to 2 years after BMS-986403 infusion
Results and safety
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986403, Fludarabine and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, run by Bristol-Myers Squibb at 9 sites in 2 countries.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
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?
Number of participants with adverse events (AEs) (time frame: Up to 2 years after BMS-986403 infusion). The study lists 6 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 18 Jul 2023.