Clinical trial · Interventional
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.
- 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 cell based prostate cancer therapy, Autologous Lymphoid Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients will receive 3 doses of the ALECSAT treatment. 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 repeated dosing of this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumor 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 (2)
- measure
- Adverse Events
- timeFrame
- At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25
- description
- To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes). AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not.
- measure
- Blood Pressure, Pulse and Temperature
- timeFrame
- At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25
- description
- Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Serum castration levels of testosterone, (total testosterone under 1.7nmol/l). 2. Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 % increases over the PSA nadir. 3. Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions. 4. Be over the age of 18 and capable of understanding the information and giving informed consent. 5. Expected survival time (life expectancy) of over 6 months. 6. Adequate performance status better than 2 (WHO/ECOG Performance status score). Exclusion Criteria: 1. A low blood count (haemoglobin \< 6.0 mmol/l). 2. Lymphocyte counts below 0.8 x 109/l. 3. Positive tests for anti-HIV-1/2; HBsAg, anti-HBc (Hepatitis B Core Antigen) and Anti-HCV (Hepatitis C Virus). 4. Syphilis i.e. being positive in a Treponema Pallidum test. 5. Uncontrolled serious bacterial, viral, fungal or parasitic infection. 6. Clinically significant autoimmune disorders or conditions of immune suppression. 7. Treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial. 8. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production. 9. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the ALECSAT clinical trial. 10. Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of side effects difficult.
References
Publications (0)
Data not yet available