Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer (ImmProCure)
Randomized Phase II Study of Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Biochemical Relapse of Prostate Cancer
This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
연구 개요
상태
정황
상세 설명
CC-1 contains a PSMA binder with particular reactivity in PC and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life, but most importantly reduces off-target T cell activation with expected fewer side effects. The multi-peptide vaccine VAC-XS15-PC01 is composed of 10 HLA-restricted antigens, comprising immunopeptidome-defined PC-associated epitopes, adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG.
The study entails three-arms: (1) the multi-peptide vaccine VAC-XS15-PC01 alone, (2) PSMAxCD3 bispecific antibody CC-1 alone and (3) combinatorial treatment of CC-1 and VAC-XS15-PC01. Up to 84 patients are recruited (n = up to 28 per arm) and patients are randomly assigned 1:1:1 (drop-out rate of 15% anticipated). A translational research program comprising, among others, a strict evaluation of prostate specific antigen (PSA) course integrated with analysis of CC-1 induced immune response and immunogenicity of VAC-XS15-PC01 serves to detect early signs of efficacy. Furthermore, safety of the investigational medical products is evaluated, and tolerability of their combination are assessed.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Susanne Jung, Dr. med.
- 전화번호: +49 (0)7071-29 83275
- 이메일: kketi@med.uni-tuebingen.de
연구 장소
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, 독일, 69120
- 아직 모집하지 않음
- NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
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연락하다:
- Stefanie Zschaebitz, Dr. med.
- 전화번호: +49 (0)6221-56-35950
- 이메일: kketi@med.uni-tuebingen.de
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Tübingen, Baden-Wurttemberg, 독일, 72076
- 모병
- CCU Transltional Immunolgy, University Hospital Tübingen
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연락하다:
- Susanne Jung, Dr. med.
- 전화번호: +49 (0)7071-29 83275
- 이메일: kketi@med.uni-tuebingen.de
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Beriln
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Berlin, Beriln, 독일, 12203
- 아직 모집하지 않음
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie
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연락하다:
- Sebastian Ochsenreither, Prof. Dr.
- 전화번호: +49 30 450 613 483
- 이메일: kketi@med.uni-tuebingen.de
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, 독일, 45147
- 아직 모집하지 않음
- Universitätsklinikum Essen, Abteilung Urologie
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연락하다:
- Darr Christopher, Dr. med.
- 전화번호: +49 (0)201 723-3210
- 이메일: kketi@med.uni-tuebingen.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Understand and voluntarily sign an IC document prior to any study related assessments/procedures
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Understand and voluntarily sign an IC document prior to any study related assessments/procedures
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Patient is able to understand and comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
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Men aged ≥ 18 and ≤80 years
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Histologic diagnosis of prostatic adenocarcinoma
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Biochemical recurrence (BCR): PSA recurrence after treatment with curative intent; PSA ≥0.2 ng/mL or PSA > nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment; AND no distant metastasis upon PSMA-PET imaging
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Patients are ineligible to receive available treatment alternatives
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Low risk of rapid disease progression, defined as:
o PSA-DT > 1 year AND pathological ISUP grade < 4 for men with prior RP OR Interval to BCR > 18 months AND biopsy ISUP grade < 4 for men with prior radiation therapy
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In case of second relapse PSA-DT > 9 months
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Eastern Cooperative Oncology Group (ECOG) performance status ≤1
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Exclusion Criteria:
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• PSA >5 ng/mL (at screening)
- Patients who are receiving or have previously received androgen deprivation treatment.
Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be >12 nmol/l.
- Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
- Clinically significant xerostomia (dry mouth >1grade according to CTCAE v6.0)
- Untreated current or prior distant metastasis of PC
- Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and non-muscle invasive bladder cancer.
- Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anti-cancer therapy
- Clinical signs of active infection (> grade 2 according to CTCAE v6.0)
- History of HIV infection
- Viral active or chronic hepatitis (HBV or HCV)
- Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (< 10 mg/ day), in the past 1 year
- Ongoing relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- Epilepsy requiring pharmacologic treatment
- Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.
- Heart failure NYHA III/IV
- Severe obstructive or restrictive ventilation disorder
- Known intolerance to CC-1, or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, VAC-XS15-PC01)
- Refrain from blood donation during the course of the study
- Male patients have to refrain from sperm donations for 6 months after last IMP
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Multi-peptide vaccine VAC-XS15-PC01
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. |
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. |
|
활성 비교기: PSMAxCD3 bispecific antibody CC-1
CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. |
CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. |
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실험적: PSMAxCD3 bispecific antibody CC-1 + Multi-peptide vaccine VAC-XS15-PC01
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 3, administered 4 weeks apart from each other. CC-1 is applied subcutaneously once per week for 12 weeks in Arm 3. Due to priming doses up to 14 applications are planned. |
The vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other. CC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline.
기간: Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT
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PSA serum levels [ng/ml] are determined during screening, before every treatment, and then every 30 days until end of follow up. PSA serum levels for one study patient should be locally assessed in the same lab during the whole study treatment. Furthermore, 5ml serum are taken and should be processed locally and stored at -80 °C at the study site. Tübingen for central assessment of PSA. |
Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ImmProCure
- 2025 (미국 NIH 보조금/계약)
- 2025-522144-41-00 (씨티스)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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