CTRI/2024/07/070765尚未招募2 期
A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer . - NI
ImmunityBio Inc Altor BioScience0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must meet ALL of the following criteria for inclusion in the study.
- •1. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
- •a. Cohort A Histologically confirmed CIS (with or without Ta or T1 disease)
- •b. Cohort B Histologically confirmed high grade papillary disease (Ta or T1 only).
- •c. Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and or T1 disease should have complete resection before study treatment.
- •d. Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy.
- •2. Currently eligible for intravesical BCG therapy.
- •3. Age greater than or equal to 18 years.
- •4. Performance status: ECOG performance status of 0, 1, or 2 (Appendix 16.3).
- •5. BCG-naive disease as defined as either of the following:
- •a. Have not received prior intravesical BCG or
- •b. Previously received BCG, but stopped receiving more than 3 years before date of randomization.
- •6. Laboratory tests performed within 21 days of treatment start:
- •a. Absolute lymphocyte count greater than or equal to Institutional lower limit of normal
- •b. Absolute neutrophil count (AGC or ANC) greater than or equal to 1,000 per micro L
- •c. Platelets greater than or equal to 100,000 per micro L (Patients may be transfused to meet this requirement)
- •d. Hemoglobin greater than or equal to 8 g per dL (Patients may be transfused to meet this requirement)
- •e. Calculated glomerular filtration rate (GFR) greater than 40 mL per min or Serum creatinine less than or equal to 1.5 x ULN
- •f. Total bilirubin less than or equal to 2.0 X ULN
- •g. AST, ALT, ALP less than or equal to 3.0 X ULN
- •using the Cockcroft-Gault equation to calculate the eGFR for this study as mentioned in study protocol.
- •7. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT greater than 50 percent FEV1 if clinically indicated by the Investigator.
- •8. Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
- •9. Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study.
- •10. Provide signed informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.
排除标准
- •Patients with ANY of the following criteria are excluded from participation in the study:
- •1. Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT or biopsy are excluded.
- •2. Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19).
- •3. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extra vesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control).
- •4. Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV (Appendix 16.4) or other clinical signs of severe cardiac dysfunction.
- •5. Severe or unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
- •6. History or evidence of uncontrollable central nervous system (CNS) disease.
- •7. Known human immunodeficiency virus (HIV)-positive.
- •8. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- •9. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions
- •10. Ongoing chronic systemic steroid therapy required (Greater than 10 mg oral prednisone daily or equivalent).
- •11. Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
- •12. Psychiatric illness or social situations that would limit compliance with study requirements.
- •13. Other illness that in the opinion of the Investigator would exclude the patient from participating in this study.
研究者
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