ImmunoBreast - A Phase Ib Study

NCT04609215 | Unknown Phase 1 DMC

• 1 other identifier: 19.07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Triple Negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer

Keywords

Breast cancer; Immunotherapy; ALECSAT; Adaptive cell transfer

Outcome Measures

Primary Outcomes (1)

• AEs and SAEs according to CTCAE v5.0.

  Safety and tolerability

  19 months

Secondary Outcomes (5)

• Efficacy ORR

  19 months

• Efficacy PFS

  19 months

• Efficacy DCR

  19 months

• Efficacy DOR

  19 months

• Efficacy OS

  19 months

Study Arms (1)

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.

Other: ALECSAT

Interventions

ALECSAT OTHER

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.

Also known as: Adoptive cell therapy

ALECSAT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Previously treated with carboplatin / gemcitabine.
• Prior therapy with ALECSAT or other cellular immunotherapies.
• 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.
• 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.

Sponsors & Collaborators

• Henrik Ditzel: lead
• CytoVac A/S: collaborator
• National Board of Health, Denmark: collaborator

Study Sites (2)

Odense University Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

Sygehus Lillebælt Vejle

Vejle, Region Syddanmark, 7100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Anette R Kodahl, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik J Ditzel, MD, PhD

CONTACT

+45-6550 3781; henrik.ditzel@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D.

Model Details: Open-label single-arm design.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: April 21, 2020
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

DK (2)