Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Immunomodulating Agents

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.

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.

ALECSAT

Henrik J Ditzel, MD, PhD

Annette R Kodahl, M.D.

Henrik J Ditzel, M.D.

Erik H Jakobsen, M.D.

Anette R Kodahl, MD, PhD

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.

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.

ImmunoBreast - A Phase Ib Study

"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"

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.

DCR according to RECIST v1.1 defined as the proportion of patients with CR, PR or stable disease (SD).

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.

OS defined as the time from initiation of study treatment to the date of death from any cause.

Spots Global Cancer Trial Database for adaptive cell transfer