Metastatic Castration-resistant Prostate CancerPhase 1NCT05533203
Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 1 study testing Prodencel; an autologous dendritic cell therapeutic tumor vaccine in people with Metastatic Castration-resistant Prostate Cancer, run by Shanghai Humantech Biotechnology Co. Ltd at 1 site in China.
Trial summary
This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Prodencel; an autologous dendritic cell therapeutic tumor vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2022to 1 Mar 2024
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically prostate adenocarcinoma, exclusion of the initially diagnosed neuroendocrine or small-cell carcinoma.
- Subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel androgen-deprived therapy and docetaxel chemotherapy. The previous antitumor treatment is ≥4 weeks prior to first dose.
- The previous clinical trials is ≥30 days prior to screening; Under the circumstance of previous clinical trials≤3 months , the pre-trial drug cannot interfere the safety and efficacy of current trial judged by the investigators.
- Age ≥18 years old when signing ICF, male, weight ≥50kg.
- Screening ECOG performance status is ≤2.
- Written information consent provided prior to the initiation of study procedures with cooperation during the follow-up.
Who cannot join
- Treatment requirement of Olaparib with the confirmed BRCA gene mutation.
- Rechallenge of docetaxel or other chemotherapy.
- Imminent Radiotherapy with radium-223.
- Plan to participate in other clinical trials.
- Pathological long bone fracture (cortical erosion > 50% on imaging) or spinal cord compression.
- History of other malignancies in the past 5 years with the exception of the following：cancer disease free≥5 years or squamous or basal cell skin carcinoma.
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- Systemic therapy of immunosuppressive agents (such as cyclosporine, tacrolimus, rapamycin, and azathioprine, etc.) within one month prior to screening.
- Use of oral, intramuscular or intravenous corticosteroids within 28 days prior to enrollment. Short-term use of corticosteroids are allowed to prevent reactions for imaging studies. Use of inhaled corticosteroids for breathing insufficiency (chronic obstructive pulmonary disease) and topical steroids are allowed.
- Positive infectious disease screening. Active HBV hepatitis (defined as positive HBsAg with HBV-DNA ≥ upper limit of normal （ULN））; Active hepatitis C (defined as HBV-Ab ≥ULN)； Positive COVID-19；Human immunodeficiency virus (HIV) infection with HIV-Ab ≥ULN；Positive syphilis with TP-Ab≥ULN.
- Myocardial infarction, unstable angina pectoris, cardiac surgery or interventional therapy within 6 months prior to enrollment. Congestive heart failure, atrial fibrillation or other poorly controlled arrhythmias.
- Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attack), craniocerebral surgery and unexplained loss of consciousness occurred within 6 months before enrollment.
- Presence of the malignant pleural effusion or malignant ascites.
- History of severe allergic reactions or allergies to the ingredients of Prodencel.
- Abnormal screening hematologic function: white blood cell count (WBC)<3.0×109/L, neutrophil count (NEUT)<1.5×10^9/L, platelet count (PLT)<100×10^9/L, hemoglobin (Hb)< 100g/L.
- Abnormal screening coagulation function: prothrombin time (PT) ≥ULN, international normalized ratio (INR) ≥ULN, thrombin time (TT) ≥ULN.
- Abnormal screening liver and kidney function: total bilirubin (TBIL) > 1.5ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5ULN; serum creatinine (SCr) > 1.5 ULN.
- History of splenectomy.
- Presence of primary or secondary immunodeficiency disease.
- History of uncontrolled seizures, central nervous system disorders, or psychotic loss of cognition.
- History of chronic alcohol or drug abuse within 6 months prior to screening.
- Unstable systemic diseases, such as active infection, liver cirrhosis, chronic renal failure, severe chronic lung diseases, etc.
- Clinically severe pericardial effusion.
- Not suitable for leukapheresis.
- For any other reasons, the patients are believed not suitable for participation in this study by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital, The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
Linhui Wang, Ph.D., +86 13901635510, wanglinhuicz@163.com
Linhui Wang, Ph.D.
About this study
Official title: A Multicenter, Non-randomized, Open-label, and Dose-escalation Phase I Study to Evaluate the Safety of Prodencel Treatment in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Read the detailed description
This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5.
- Being tested
- Prodencel; an autologous dendritic cell therapeutic tumor vaccine
- Keywords
- metastatic castration-resistant prostate cancer, dendritic cell vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prodencel; an autologous dendritic cell therapeutic tumor vaccineBiological
Subcutaneous injection, each injection point should not exceed 1ml.
| Study group | Role | What they receive |
|---|---|---|
| Prodencel Treated for mCRPC | Experimental | Cohort 1: Each subject would receive Prodencel treatment at a dose of 5×10^6 cells every two weeks for a total of 3 doses.
Cohort 2: Each subject would receive Prodencel treatment at a dose of 10×10^6 cells every two weeks for a total of 3 doses.
Cohort 3: Each subject would receive Prodencel treatment at a dose of 15×10^6 cells every two weeks for a total of 3 doses.
Cohort 4: The safe and effective dose from cohort 1-3 is recommended for booster immunization of cohort 4. Subjects will receive additional Prodencel treatment every 4 weeks, until disease progression or intolerance after the 3 doses of immune induction, to evaluate the safety and tolerability of the booster immunization. Receives: Biological: Prodencel; an autologous dendritic cell therapeutic tumor vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (AEs) during Induction Immunization
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 2 weeks after the third administration
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events (AEs) during Booster Immunization
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start8 Aug 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Humantech Biotechnology Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Responsible party
- Sponsor
- Investigators
- Linhui Wang, Ph.D., Principal investigator, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533203
- Sponsor's protocol ID
- HTB-B003-I
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-randomized, Open-label, and Dose-escalation Phase I Study to Evaluate the Safety of Prodencel Treatment in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT05533203
- Acronym / sponsor ID
- HTB-B003-I
- Keywords
- metastatic castration-resistant prostate cancer, dendritic cell vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Humantech Biotechnology Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Sep 2022 (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.
This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prodencel Treated for mCRPC | Experimental | Biological: Prodencel; an autologous dendritic cell therapeutic tumor vaccineCohort 1: Each subject would receive Prodencel treatment at a dose of 5×10^6 cells every two weeks for a total of 3 doses. Cohort 2: Each subject would receive Prodencel treatment at a dose of 10×10^6 cells every two weeks for a total of 3 doses. Cohort 3: Each subject would receive Prodencel treatment at a dose of 15×10^6 cells every two weeks for a total of 3 doses. Cohort 4: The safe and effective dose from cohort 1-3 is recommended for booster immunization of cohort 4. Subjects will receive additional Prodencel treatment every 4 weeks, until disease progression or intolerance after the 3 doses of immune induction, to evaluate the safety and tolerability of the booster immunization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically prostate adenocarcinoma, exclusion of the initially diagnosed neuroendocrine or small-cell carcinoma.
- Subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel androgen-deprived therapy and docetaxel chemotherapy. The previous antitumor treatment is ≥4 weeks prior to first dose.
- The previous clinical trials is ≥30 days prior to screening; Under the circumstance of previous clinical trials≤3 months , the pre-trial drug cannot interfere the safety and efficacy of current trial judged by the investigators.
- Age ≥18 years old when signing ICF, male, weight ≥50kg.
- Screening ECOG performance status is ≤2.
Key exclusion criteria (24 listed)
- Treatment requirement of Olaparib with the confirmed BRCA gene mutation.
- Rechallenge of docetaxel or other chemotherapy.
- Imminent Radiotherapy with radium-223.
- Plan to participate in other clinical trials.
- Pathological long bone fracture (cortical erosion > 50% on imaging) or spinal cord compression.
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 |
|---|---|---|
| Prodencel; an autologous dendritic cell therapeutic tumor vaccineSubcutaneous injection, each injection point should not exceed 1ml. | Biological | Prodencel Treated for mCRPC |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (AEs) during Induction Immunization
Time frame: Up to 2 weeks after the third administration
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events (AEs) during Booster Immunization
Time frame: Up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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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.
Linhui Wang, Ph.D. principal investigator
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prodencel; an autologous dendritic cell therapeutic tumor vaccine in people with Metastatic Castration-resistant Prostate Cancer, run by Shanghai Humantech Biotechnology Co. Ltd at 1 site in China.
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 6 inclusion and 24 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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.
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 Guoyou Chen, Ph.D. (+86 13601923503, guoyouchen@humtech.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (AEs) during Induction Immunization (time frame: Up to 2 weeks after the third administration). 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 23 Jan 2023.