EUCTR2015-005382-23-GB进行中（未招募）1 期
Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Patients With Follicular Non-Hodgkin’s Lymphoma
Immune Design Ltd0 个研究点目标入组 143 人开始时间: 2016年2月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 143
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Follicular low grade NHL, (grades 1, 2, 3A) either treatment naïve or relapsed or refractory following at least one prior treatment. For france, patients with either relapsed or refractory only. In Part 1 Dose Escalation only, in addition to follicular NHL, marginal zone B cell lymphomas: either treatment naïve or relapsed or refractory following at least one prior treatment. In Part 4, enrollment is limited to relapsed or refractory follicular NHL patients who hasve received at least 3 treatments, one of which was or included an anti-CD20 antibody. In Part 5, enrollment will include relapsed or refractory CD20+ follicular NHL following at least one but not more than 2 prior treatments.
- •2. Tumour mass(es) accessible for intratumoral injection and are being considered for local radiation therapy and at least one additional site of disease outside the radiation field for assessment of distal (abscopal) response (Imaging assisted injections are allowed following approval by Medical Monitor). For Parts 4 and 5, radiation therapy is omitted. Measurable tumour mass(es) accessible for intratumoral injections must be present for treatment and assessment of response.
- •3. = 18 years of age
- •4. Life expectancy of = 6 months per the investigator
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. ECG without evidence of clinically significant arrhythmia or ischemia
- •7. If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use 2 methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment.
- •8. If male and sexually active with a FCBP, must agree to use effective contraception such as latex condom or is sterile (e.g. following surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 143
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Cancer therapies, including chemotherapy, radiation (non-study regimen related), biologics or kinase inhibitors, G-CSF or GM-CSF within 4 weeks prior to the first scheduled G100 dose
- •2. Investigational therapy within 4 weeks prior to G100 dosing
- •3. Prior administration of G100 or other intratumoral immunotherapeutics
- •4. Inadequate organ function including:
- •a. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophil count = 1500/mm3, platelets < 75000/mm3, or haemoglobin < 10 gm/dL
- •b. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total
- •serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is
- •=3.0 mg/dL)
- •c. Renal: Creatinine > 1.5x ULN
- •d. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
- •5. Significant immunosuppression from:
- •a. Concurrent, recent (= 4 weeks ago) or anticipated treatment with systemic corticosteroids at any
- •b. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or
- •conditions such as common variable hypogammaglobulinemia
- •6. Pregnant or nursing
- •7. Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York
- •Heart Association (NYHA) Grade III or IV heart failure
- •8. History of other cancer within 2 years (except non-melanoma cutaneous malignancies and cervical
- •carcinoma in situ)
- •9. Recent (< 1 week ago) clinically significant infection, active tuberculosis or evidence of active hepatitis B, hepatitis C or HIV infection
- •10. Central nervous system involvement with lymphoma, including parenchymal and leptomeningeal disease. In Parts 4 and 5, any involvement with lymphoma in a closed or confined space such as the retroorbital area will need to be pre-approved by the Medical Monitor.
- •11. Significant autoimmune disease, including active non-infectious pneumonitis, with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or
- •were transient and have completely resolved and require no ongoing therapy. (Replacement therapy for hypothyroidism or diabetes is allowed.)
- •12. Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent
- •13. History of significant adverse or allergic reaction to any component of G100 and if enrolled in Part 2, anti-PD-1 antibodies pembrolizumab and/or any of its excipients, and if enrolled in Part 5, anti-CD20 antibodies including rituximab as excipients
- •14. Use of anti-coagulant agents or history a significant bleeding
- •diathesis. (If a superficial lymph node or subcutaneous mass is to be
- •injected, patients on agents such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or clopidogrel are eligible and these agents do not have to be withheld. For procedures with moderate or significant risk of bleeding, long-acting agen
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