Triple Negative Breast CancerPhase 1/2NCT04609215
ImmunoBreast - A Phase Ib Study
A Phase 1/2 study testing ALECSAT in people with Triple Negative Breast Cancer and Breast Cancer, run by Henrik Ditzel at 2 sites in Denmark.
Trial summary
A phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- ALECSAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 21 Apr 2020to 21 May 2023
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed informed consent to study participation. The patient may also provide consent for Future Biomedical Research (FBR). However, the patient may participate in the main study without participating in FBR.
- Female patients aged 18 years and older.
- Have locally advanced inoperable breast which cannot be treated with curative intent OR have metastatic breast cancer.
- Have a histologically or cytologically TNBC (defined by absence of HER2 and estrogen receptor (ER) expression on primary tumor) confirmed by local pathologist. Patients initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
- Able and willing to provide a fresh tumor biopsy from a local recurrence or distant metastasis site.
- Eligible for chemotherapy with carboplatin and gemcitabine.
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- WHO Performance status 0-1.
- Has received no more than two prior regimens for locally advanced or metastatic breast cancer. Prior therapy with checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4) agent is allowed.
- Have measurable disease based on RECIST 1.1 as determined by local radiology review.
- Have life expectancy ≥3 months at time of enrollment.
- Demonstrate adequate organ function, within 10 days prior to the start of study treatments, as defined:
- Hematological:
- Absolute neutrophil count (ANC) ≥1,500/μL, Lymphocyte count >0.3 x 109/L. Platelets ≥100,000/μL, Renal Creatinine ≤1.5 × ULN OR measured creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN) Hepatic Total bilirubin ≤1.5 ×ULN ASAT and ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases), Albumin ≥3.0 g/dL
- Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the study.
Who cannot join
- Previously treated with carboplatin / gemcitabine.
- Prior therapy with ALECSAT or other cellular immunotherapies.
- Is currently participating in a clinical study and receiving an investigational agent or has participated in a clinical study and received an investigational agent within 4 weeks prior to inclusion or during the trial.
- Has not recovered (to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy (alopecia excluded). Prior to inclusion, the patient must have recovered adequately from any toxicity and/or complications associated with any recent procedure.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Has a diagnosis of immunodeficiency.
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- Positive blood tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis).
- Patients who have been exposed to high risk contagious virus within a reasonable time prior to enrolment, e.g., by travelling in areas with known high risk of infection or known epidemics.
- This includes but is not limited to:
- West Nile virus (in season): Less than 28 days following return from affected area; less than 6 months following full recovery from known West Nile virus infection or symptoms suggestive of West Nile virus infection
- Dengue virus: Less than 28 days following return from affected area or cessation of symptoms (include high fever, joint pain, body pain, and/or rash) in case of confirmed Dengue virus infection; less than 6 months following full recovery from diagnosis of dengue hemorrhagic fever.
- Zika virus: Less than 28 days following return from an affected area or after sexual contact with a male who has been diagnosed with Zika virus infection or with a male who travelled or lived in a Zika affected area during the three months prior to the sexual contact; less than 60 days following recovery of symptoms in case of confirmed Zika virus infection.
- Ebola virus: Less than 60 days after return from an affected area; Patients previously diagnosed with Ebola virus should be excluded from the study
- Patients from high incidence areas for Human T-Lymphotropic Virus type 1 (HTLV-1) or who has a parent from a high incidence area or who has had sexual contact with a partner from a high incidence.
- area must be excluded unless tested negative for HTLV-1
- Blood transfusion with whole blood or red blood cells within 48 hours prior to the donation of blood for ALECSAT production.
- Has an active infection requiring systemic therapy.
- Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
- Patients with symptomatic brain metastases. Patients previously treated or untreated for brain metastases that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks and max size 20 mm are allowed to be enrolled. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive antiepileptic drugs or corticosteroid treatment indicated for brain metastasis.
- Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the investigational drug.
- Females who are pregnant, planning to become pregnant or breastfeeding.
- Has received a live vaccine within 30 days prior to inclusion.
- Patients known or suspected not being able to comply with the study related study procedures.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Odense University Hospital
Odense, Fyn, 5000
Annette R Kodahl, M.D., annette.kodahl@rsyd.dk
Henrik J Ditzel, M.D., henrik.ditzel@rsyd.dk
- Not yet recruiting
Sygehus Lillebælt Vejle
Vejle, Region Syddanmark, 7100
Erik H Jakobsen, M.D., Erik.Hugger.Jakobsen@rsyd.dk
About this study
Official title: "ImmunoBreast - A Phase Ib Study to Investigate the Safety, Tolerability and Trends of Efficacy of ALECSAT Treatment as an add-on Therapy to Carboplatin and Gemcitabine in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer"
A phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer.
Read the detailed description
This is a phase Ib, dual-center, open-label, single-arm, clinical study to determine the safety, tolerability and trends of efficacy of ALECSAT as an add-on therapy to standard treatment with carboplatin and gemcitabine in female patients with locally advanced inoperable or metastatic TNBC, which has received no more than two prior systemic therapies for mTNBC.
Study treatments will continue until any of the following occurs: disease progression is locally verified using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); unacceptable toxicity; intercurrent illness that necessitates discontinuation of study treatment; Investigator's decision to withdraw the patient; pregnancy; patient noncompliance with study treatment or procedure requirements; withdrawal of consent to treatment; death; end-of-treatment visit at month 18; or other administrative reasons requiring cessation of study treatment. If chemotherapy is discontinued during the study, the patient will be allowed to continue in the study on ALECSAT treatment after discontinuation of chemotherapy, based on the Investigator's judgement. In addition, if clinical assessments indicate an anti-cancer effect of ALECSAT treatment (at the discretion of the investigator) at end of study, patients will be offered to continue ALECSAT treatment after end of the study under approved named patient use. Response assessment according to RECIST v1.1 will be performed at weeks 9 (±7 days), 18 (±7 days), and 27 (±7 days) after treatment start as by local hospital standards. Imaging will continue every 9 weeks (±7 days) thereafter during the first year, independent of any treatment delays. Response assessment will be performed every 12 weeks (±7 days) after the first year. Safety will be monitored according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (v5.0). Patients who discontinue study treatments for reasons other than PD will continue post-treatment imaging studies for disease status follow-up as per protocol, i.e., every 9 weeks (± 7 days) and 12 weeks (± 7 days) during the first year or second year of study participation, until disease progression, start of a non-study anticancer treatment, withdrawal of consent to study participation, death, or end-of-treatment visit 18 months.
- Being tested
- ALECSAT
- Keywords
- Breast cancer, Immunotherapy, ALECSAT, Adaptive cell transfer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALECSATOther
Also called Adoptive cell therapy
Patients will receive concurrent chemotherapy with carboplatin/gemcitabine with cycles repeated every 3 weeks.
During the loading phase, patients will receive ALECSAT at 28 days intervals at weeks 5, 9, and 13. Hereafter (the maintenance phase), ALECSAT will be administered every 12 weeks until disease progression, death, unacceptable toxicity, investigator/patient decision or EOT visit at 18 months.
| Study group | Role | What they receive |
|---|---|---|
| ALECSAT | Experimental | This is an exploratory single arm study. 20 patients will be included with the objective to investigate the safety, tolerability and trends of efficacy of ALECSAT for the treatment of recurrent TNBC.
ALECSAT is a form of adoptive cell therapy medicinal product. ALECSAT is an abbreviation for Autologous Lymphoid Effector Cells Specific Against Tumor. ALECSAT is an autologous product that induces an immune response against a broad repertoire of CTAs expressed on cancer cells (including TNBC) leading to killing of these cells.
Patients will receive standard treatment with carboplatin and gemcitabine along with ALECSAT. Receives: Other: ALECSAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs according to CTCAE v5.0.
Safety and tolerability
Measured: 19 months
Secondary outcomes (5)
Efficacy ORR
ORR according to RECIST v1.1
Measured: 19 months
Efficacy PFS
PFS according to RECIST v1.1, from the initiation of study treatment to the time of radiographic progression or death from any cause during the study.
Measured: 19 months
Efficacy DCR
DCR according to RECIST v1.1 defined as the proportion of patients with CR, PR or stable disease (SD).
Measured: 19 months
Efficacy DOR
DOR according to RECIST v1.1 defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression or death from any cause on study, whichever occurs first.
Measured: 19 months
Efficacy OS
OS defined as the time from initiation of study treatment to the date of death from any cause.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start21 Apr 2020
- Primary completion21 May 2023 (estimated)
- Study completion21 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label single-arm design.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Ditzel
- Sponsor type
- University, hospital or other
- Collaborators
- CytoVac A/S, National Board of Health, Denmark
- Responsible party
- Sponsor-investigator, Henrik Ditzel, Odense University Hospital
- Investigators
- Anette R Kodahl, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609215
- Sponsor's protocol ID
- 19.07
- Status last verified
- Apr 2022
- First submitted
- 23 Oct 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ImmunoBreast - A Phase Ib Study to Investigate the Safety, Tolerability and Trends of Efficacy of ALECSAT Treatment as an add-on Therapy to Carboplatin and Gemcitabine in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer"
- ClinicalTrials.gov ID
- NCT04609215
- Acronym / sponsor ID
- 19.07
- Keywords
- Breast cancer, Immunotherapy, ALECSAT, Adaptive cell transfer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henrik DitzelUniversity, hospital or other
- Collaborators
- CytoVac A/S, National Board of Health, Denmark
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 21 May 2023 (estimated)
- Study completion
- 21 May 2023 (estimated)
- First posted
- 30 Oct 2020 (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.
A phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer.
Detailed description
This is a phase Ib, dual-center, open-label, single-arm, clinical study to determine the safety, tolerability and trends of efficacy of ALECSAT as an add-on therapy to standard treatment with carboplatin and gemcitabine in female patients with locally advanced inoperable or metastatic TNBC, which has received no more than two prior systemic therapies for mTNBC.
Study treatments will continue until any of the following occurs: disease progression is locally verified using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); unacceptable toxicity; intercurrent illness that necessitates discontinuation of study treatment; Investigator's decision to withdraw the patient; pregnancy; patient noncompliance with study treatment or procedure requirements; withdrawal of consent to treatment; death; end-of-treatment visit at month 18; or other administrative reasons requiring cessation of study treatment. If chemotherapy is discontinued during the study, the patient will be allowed to continue in the study on ALECSAT treatment after discontinuation of chemotherapy, based on the Investigator's judgement. In addition, if clinical assessments indicate an anti-cancer effect of ALECSAT treatment (at the discretion of the investigator) at end of study, patients will be offered to continue ALECSAT treatment after end of the study under approved named patient use. Response assessment according to RECIST v1.1 will be performed at weeks 9 (±7 days), 18 (±7 days), and 27 (±7 days) after treatment start as by local hospital standards. Imaging will continue every 9 weeks (±7 days) thereafter during the first year, independent of any treatment delays. Response assessment will be performed every 12 weeks (±7 days) after the first year. Safety will be monitored according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (v5.0). Patients who discontinue study treatments for reasons other than PD will continue post-treatment imaging studies for disease status follow-up as per protocol, i.e., every 9 weeks (± 7 days) and 12 weeks (± 7 days) during the first year or second year of study participation, until disease progression, start of a non-study anticancer treatment, withdrawal of consent to study participation, death, or end-of-treatment visit 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label single-arm design.
| Arm | Type | Receives |
|---|---|---|
| ALECSAT | Experimental | Other: ALECSATThis is an exploratory single arm study. 20 patients will be included with the objective to investigate the safety, tolerability and trends of efficacy of ALECSAT for the treatment of recurrent TNBC. ALECSAT is a form of adoptive cell therapy medicinal product. ALECSAT is an abbreviation for Autologous Lymphoid Effector Cells Specific Against Tumor. ALECSAT is an autologous product that induces an immune response against a broad repertoire of CTAs expressed on cancer cells (including TNBC) leading to killing of these cells. Patients will receive standard treatment with carboplatin and gemcitabine along with ALECSAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have signed informed consent to study participation. The patient may also provide consent for Future Biomedical Research (FBR). However, the patient may participate in the main study without participating in FBR.
- Female patients aged 18 years and older.
- Have locally advanced inoperable breast which cannot be treated with curative intent OR have metastatic breast cancer.
- Have a histologically or cytologically TNBC (defined by absence of HER2 and estrogen receptor (ER) expression on primary tumor) confirmed by local pathologist. Patients initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
- Able and willing to provide a fresh tumor biopsy from a local recurrence or distant metastasis site.
Key exclusion criteria (23 listed)
- Previously treated with carboplatin / gemcitabine.
- Prior therapy with ALECSAT or other cellular immunotherapies.
- Is currently participating in a clinical study and receiving an investigational agent or has participated in a clinical study and received an investigational agent within 4 weeks prior to inclusion or during the trial.
- Has not recovered (to ≤Grade 1 or to baseline) from AEs due to a previously administered therapy (alopecia excluded). Prior to inclusion, the patient must have recovered adequately from any toxicity and/or complications associated with any recent procedure.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
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 |
|---|---|---|
| ALECSATAlso: Adoptive cell therapyPatients will receive concurrent chemotherapy with carboplatin/gemcitabine with cycles repeated every 3 weeks. During the loading phase, patients will receive ALECSAT at 28 days intervals at weeks 5, 9, and 13. Hereafter (the maintenance phase), ALECSAT will be administered every 12 weeks until disease progression, death, unacceptable toxicity, investigator/patient decision or EOT visit at 18 months. | Other | ALECSAT |
Primary outcome
AEs and SAEs according to CTCAE v5.0.
Time frame: 19 months
Safety and tolerability
5 secondary outcomes
Efficacy ORR
Time frame: 19 months
Efficacy PFS
Time frame: 19 months
Efficacy DCR
Time frame: 19 months
Efficacy DOR
Time frame: 19 months
Efficacy OS
Time frame: 19 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
Anette R Kodahl, MD, PhD principal investigator
Principal Investigator
2 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 ALECSAT in people with Triple Negative Breast Cancer and Breast Cancer, run by Henrik Ditzel at 2 sites in Denmark.
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 14 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik J Ditzel, MD, PhD (+45-6550 3781, henrik.ditzel@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs according to CTCAE v5.0. (time frame: 19 months). 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 20 Apr 2022.