A Phase 1/2 Study of G100 Therapy injected directly into the tumor or in combination with Pembrolizumab or Rituximab in patients with Follicular non-Hodgkin's Lymphoma.
- Conditions
- follicular non-Hodgkin's lymphomaMedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005382-23-GB
- Lead Sponsor
- Immune Design Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 143
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
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
dose, or
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method