Clinical trial · Interventional
Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a phase I study of a new cell based prostate cancer therapy (ALECSAT). In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumour cells and in this way stop or slow down the progression of disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALECSAT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary endpoint is to show safety and tolerability for the administration of ALECSAT to enable further clinical development of the ALECSAT therapy.
- timeFrame
- Within 7 weeks
Secondary outcomes (1)
- measure
- The secondary endpoint for this study is to establish if any indications of a positive therapeutic effect on the prostate cancer may be observed.
- timeFrame
- Within 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hormone-refractory prostate cancer patients * Three consecutive rises of PSA min. 2 weeks apart, resulting in at least two 50% increases over the PSA nadir. * Antiandrogen withdrawal for at least 4 weeks, or * PSA progression despite secondary hormonal manipulations, or * Progression of osseous or soft tissue lesions. * Serum castration levels of testosterone. * Be capable of understanding the information and giving informed consent. * Expected survival time (life expectancy) of over 4 months. * Adequate performance status (WHO / ECOG Performance status score 2 or less). Exclusion Criteria: * Patients with a low blood count (haemoglobin \< 6.0 mmol/l). * Patients with lymphocyte-numbers below 0.8. * Patients known to be HIV and/or hepatitis positive i.e. patients positive in tests for anti-HIV-1/2; HBsAg, anti-HBc and Anti-HCV. * Patients known to have syphilis i.e. being positive in a Treponema Pallidum test. * Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection. * Patients must have no clinically significant autoimmune disorders or conditions of immune suppression. * Patients that have been treated with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial. * Fertile patients. * Patients that have received blood transfusions within 48 hours prior to donation of blood for ALECSAT production. * Patients must not have been included in other clinical trials 6 weeks prior to inclusion in the trial or be enrolled in other clinical trials during the ALECSAT clinical trial. * Any medical condition that will render participation in the study risky or, according to the investigator in charge, will make the assessment of side-effects difficult.
References
Publications (1)
- DERIVEDGammelgaard OL, Ehmsen S, Jylling AMB, Sandberg L, Kirkin AF, Kodahl AR, Ditzel HJ. Adoptive cell transfer therapy with ex vivo primed peripheral lymphocytes in combination with chemotherapy in locally advanced or metastatic triple-negative breast cancer: the ImmunoBreast phase Ib clinical trial. J Immunother Cancer. 2025 Dec 4;13(12):e012213. doi: 10.1136/jitc-2025-012213. PMID 41344991