Study of Anti-PSMA CAR NK Cell in Castration-Resistant Prostate Cancer
Sponsor:
Allife Medical Science and Technology Co., Ltd.
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 29, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | December 2018 | ||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Occurrence of treatment related adverse events as assessed by CTCAE v4.0[ Time Frame: Day 3-Year 2 after injection ] Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Study of Anti-PSMA CAR NK Cell in Castration-Resistant Prostate Cancer |
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| Official Title ICMJE | Clinical Study on the Safety and Efficacy of Anti-PSMA CAR Car NK Cells in Castration-resistant Prostate Cancer (CRPC) |
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| Brief Summary | This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-PSMA CAR NK cells in patients with castration-resistant prostate cancer. |
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| Detailed Description | This is a Phase I study evaluating the safety and feasibility of anti-PSMA CAR NK cells in a 3+3 dose escalation design. The Cohort subjects (N=3 or 6) will receive a single dose of 0.5-3 x 107/kg anti-PSMA CAR NK cells on day 0, following a single dose of 60mg/kg of cyclophosphamide administered up to 6-7 days prior to the CAR NK cells. If the number of manufactured CAR NK cells does not meet the pre-specified minimum infused dose of 1 x 107/kg cells, then dose will not be administered, and the subject will be replaced in the study. If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs, the study will advance to Cohort 2. If 2 DLT/3 subjects occurs at dose of 1-3 x 107/kg cells, then enrollment in this Cohort will be stopped.The members of Committee on Safety of Drugs will be evaluate safety,and the dose will be de-escalated | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Early Phase 1 | ||
| Study Design ICMJE | Allocation: Intervention Model: Sequential Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
9 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 2021 | ||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Castration-Resistant Prostate Cancer, as defined by： Serum testosterone<50ng/dl or <1.7nmol/L. Increase in serum PSA of at least 25% and an absolute increase of 2ng/ml or more from nadir for at least three weeks. 2. Castration-Resistant Prostate Cancer≥10% tumor cells expressing PSMA as demonstrated by immunohistochemistry analysis on fresh tissue. 3. Patients > 18 years of age 4. ECOG performance status of 0 - 1 5. Adequate organ function, as defined by: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min Serum total bilirubin < 1.5x ULN Serum ALT/AST < 2x ULN 6. Adequate hematologic reserve within 4 weeks of study enrollment as defined by: Hgb > 10 g/dl PLT > 100 k/ul ANC > 1.5 k/ul Note: Subjects must not be transfusion dependent 7. Prior therapy with at least one standard 17α lyase inhibitor or second-generation anti-androgen therapy for the treatment of metastatic castrate resistant prostate cancer 8. Provides written informed consent 9. Subjects of reproductive potential must agree to use acceptable birth control methods Exclusion Criteria: 1. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies (such as SipuleucelT, PROSTVAC), immune checkpoint inhibitors,radium-223 and immunoconjugate therapies. 2. History of an active non-curative non-prostate primary malignancy within the prior 5 years 3. Subjects with a rising PSA, but who have never had radiologic evidence of metastatic disease(i.e. 'biochemical recurrence') 4. Subjects who require the chronic use of systemic corticosteroid therapy 5. Subjects who have received > 3 prior therapies for the treatment of castrate resistant prostate cancer (excluding luteinizing hormone-releasing hormone agonists or antagonists, or first generation anti-androgen therapies). This includes subjects who received Taxotere in noncastrate setting. 6. Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification 7. Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging) 8. History of active autoimmune disease requiring immunosuppressive therapy 9. Patients with serious infection. 10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO) 11. Active hepatitis B (HBV DNA＞1000copy/mL), hepatitis C or HIV infection. 12. history of definite neurological or psychiatric disorders, including epilepsy or dementia. 13. Subjects with drug abuse,alcohol dependence,psychological or social conditions may interfere with the study or evaluate the results of the study. 14. Subjects who have other conditions that were not appropriate for the group determined by the researchers. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Allife Medical Science and Technology Co., Ltd. | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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