Metastatic Castration-resistant Prostate CancerEarly Phase 1NCT03692663
Study of Anti-PSMA CAR NK Cell (TABP EIC) in Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study testing TABP EIC, Cyclophosphamide and fludarabine in people with Metastatic Castration-resistant Prostate Cancer, run by Allife Medical Science and Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of TABP EIC in patients with Metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- TABP EIC, Cyclophosphamide and fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to Jun 2024
- Phase
- Early 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To enter the trial, subjects had to meet all of the following eligibility criteria:
- diagnosed metastatic castration-resistant prostate cancer (mCRPC);
- Castration level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L);
- Positive expression of PSMA;
- According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:
- A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA > 2 ng/mL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter > 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);
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- Expected survival time ≥6 months;
- Toxicity of any previous treatment had recovered to ≤ grade 1 at the time of enrollment (except hair loss and hearing loss);
- ECOG score of patients 0-1;
- Patients voluntarily participated and signed the informed consent, and followed the trial treatment plan and visit plan.
Who cannot join
- Subjects who meet one of the following conditions will not be enrolled in the trial:
- Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
- Previous treatment with any PSMA-targeted therapy;
- radiotherapy was administered within 4 weeks prior to the start of study treatment;
- Patients with a history of biological macromolecule drug allergy;
- Abnormal function of major organs:
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- Neutrophil count (ANC) < 1.5×109/L; Platelet count (Plt) < 100×109/L; Hemoglobin (Hb) < 9 g/dL; B. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN (≥5×ULN for liver metastases); C. Renal function: serum creatinine (Cr) ≥1.5×ULN; D. Prothrombin time (PT) > 15 s, activated partial thrombin time (APTT) was prolonged or shortened by more than 10 s (normal reference value 23 s-37 s), or international normalized ratio (INR) > 1.7; E. Pulmonary function: Severe respiratory diseases (active pulmonary tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- Patients required systemic long-term steroid use or had received systemic steroids (dose equivalent to prednisone >10 mg/ day, except for patients using inhaled hormones) or other immunosuppressive agents 30 days before enrollment;
- A history of severe central nervous system disorders, such as stroke or epilepsy;
- active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;
- have had other malignancies other than prostate cancer (other than basal or squamous cell skin cancer) in the past 5 years that are currently clinically significant and require intervention;
- Clinically significant heart disease (New York Heart Association class III/IV, left ventricular ejection fraction < 60%);
- Any active (viral, bacterial, fungal) infection currently being treated or any infection requiring intravenous antibiotics for 7 or more days or intervals during the past 6 weeks or any active infection requiring oral antibiotics during the past 1 week;
- untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA≥1000 copies /mL, or active hepatitis C patients;
- Patients who have participated in other clinical trials and used study drugs within 3 months;
- In the opinion of the investigator, there are other factors that are not suitable for inclusion or affect the participant's participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin pepole's hosptial
Tianjin, 300000
Huaqing Wang, Doctor, 18622221223, huaqingw@163.com
Jian Li, Doctor, 13032231038, lijian_2016tj@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Metastatic Castration-resistant Prostate Cancer (mCRPC)
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of TABP EIC in patients with Metastatic castration-resistant prostate cancer.
- Being tested
- TABP EIC, Cyclophosphamide, fludarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TABP EICDrug
A single dose of 0.5, 10, and 30 million TABP EIC will be iv administered at D0, D7, and D14.
CyclophosphamideBiological
Cyclophosphamide will be iv administered with 250 mg/m^2 at D-3, D-2, and D-1 before TABP EIC infusion.
fludarabineBiological
Fludarabine will be iv administered with 25 mg/m^2 at D-3, D-2, and D-1 before TABP EIC infusion.
| Study group | Role | What they receive |
|---|---|---|
| TABP EIC treatment group | Experimental | Drug: TABP EIC Experimental Interventional Therapy Receives: Drug: TABP EIC; Biological: Cyclophosphamide; Biological: fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related adverse events as assessed by CTCAE v5.0
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Measured: Baseline to 1 year post infusion
Secondary outcomes (5)
The pharmacokinetic analysis of TABP EIC
Changes in the number of CD56+/ CD3-TABP EIC in peripheral blood over time
Measured: D0, D1, D3, D7, D8, D10, D14, D15, D17, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
The pharmacodynamics analysis of TABP EIC
Changes of total prostate specific antigen (tPSA) and free prostate specific antigen (fPSA) in peripheral blood
Measured: Baseline to infusion date, D28±1, D60±2, D120±2, D180±7, D270±7, 和 D365±7
The proportion of patients with a decrease in PSA levels from baseline.
PSA response rate
Measured: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Progression-free survival (PFS) after TABPEIC infusion
Survival time of patients
Measured: Baseline to 1 year post infusion
Time to clinical progression
The time from baseline to the appearance of increased PSA levels or imaging progression.
Measured: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Dec 2018
- Primary completionJun 2023 (estimated)
- Study completionJun 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin People's Hospital
- Responsible party
- Sponsor
- Investigators
- Huaqing Wang, Doctor, Principal investigator, Oncology of Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, TianjinJian Li, Doctor, Principal investigator, Urinary surgeryof Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, Tianjin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692663
- Sponsor's protocol ID
- TABP EIC-01
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2018
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT03692663
- Acronym / sponsor ID
- TABP EIC-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin People's Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Oct 2018 (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.
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of TABP EIC in patients with Metastatic castration-resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TABP EIC treatment group | Experimental | Drug: TABP EIC, Biological: Cyclophosphamide, Biological: fludarabineDrug: TABP EIC Experimental Interventional Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosed metastatic castration-resistant prostate cancer (mCRPC);
- Castration level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L);
- Positive expression of PSMA;
- According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:
- A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA > 2 ng/mL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter > 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);
Key exclusion criteria (16 listed)
- Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;
- Previous treatment with any PSMA-targeted therapy;
- radiotherapy was administered within 4 weeks prior to the start of study treatment;
- Patients with a history of biological macromolecule drug allergy;
- Abnormal function of major organs:
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 |
|---|---|---|
| TABP EICA single dose of 0.5, 10, and 30 million TABP EIC will be iv administered at D0, D7, and D14. | Drug | TABP EIC treatment group |
| CyclophosphamideCyclophosphamide will be iv administered with 250 mg/m^2 at D-3, D-2, and D-1 before TABP EIC infusion. | Biological | TABP EIC treatment group |
| fludarabineFludarabine will be iv administered with 25 mg/m^2 at D-3, D-2, and D-1 before TABP EIC infusion. | Biological | TABP EIC treatment group |
Primary outcome
Occurrence of treatment related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to 1 year post infusion
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
5 secondary outcomes
The pharmacokinetic analysis of TABP EIC
Time frame: D0, D1, D3, D7, D8, D10, D14, D15, D17, D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
The pharmacodynamics analysis of TABP EIC
Time frame: Baseline to infusion date, D28±1, D60±2, D120±2, D180±7, D270±7, 和 D365±7
The proportion of patients with a decrease in PSA levels from baseline.
Time frame: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Progression-free survival (PFS) after TABPEIC infusion
Time frame: Baseline to 1 year post infusion
Time to clinical progression
Time frame: Baseline to D28±1, D60±2, D120±2, D180±7, D270±7, and D365±7 post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Huaqing Wang, Doctor principal investigator
Oncology of Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, Tianjin
Jian Li, Doctor principal investigator
Urinary surgeryof Tianjin people's hospital, 190 Jianyuan Road, Hongqiao District, Tianjin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TABP EIC, Cyclophosphamide and fludarabine in people with Metastatic Castration-resistant Prostate Cancer, run by Allife Medical Science and Technology 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 10 inclusion and 16 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 1 Aug 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Huaqing Wang, Doctor (18622221223, huaqingw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related adverse events as assessed by CTCAE v5.0 (time frame: Baseline to 1 year post infusion). 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 1 Aug 2022.