Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT05533203 | Unknown Phase 1

• 1 other identifier: HTB-B003-I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

metastatic castration-resistant prostate cancer; dendritic cell vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 weeks after the third administration

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (AEs) during Booster Immunization

  Up to approximately 1 year

Study Arms (1)

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.

Biological: Prodencel; an autologous dendritic cell therapeutic tumor vaccine

Interventions

Prodencel; an autologous dendritic cell therapeutic tumor vaccine BIOLOGICAL

Subcutaneous injection, each injection point should not exceed 1ml.

Prodencel Treated for mCRPC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Humantech Biotechnology Co. Ltd: lead
• Shanghai Changhai Hospital,The First Affiliated Hospital of Naval Medical University: collaborator

Study Sites (1)

Shanghai Changhai Hospital, The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

• Linhui Wang, Ph.D.

  Shanghai Changhai Hospital,The First Affiliated Hospital of Naval Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoyou Chen, Ph.D.

CONTACT

+86 13601923503; guoyouchen@humtech.com.cn

Yingming Jiang, Ph.D.

CONTACT

+86 13501676984; jiangyingming@humtech.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 8, 2022
• Study Start: August 8, 2022
• Primary Completion: August 30, 2023
• Study Completion: March 1, 2024
• Last Updated: January 23, 2023

Record last verified: 2022-09

Locations

CN (1)