A Phase 1/2 Study of G100 Therapy injected directly into the tumor or in combination with Pembrolizumab of patients with Follicular non-Hodgkin's Lymphoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Follicular low grade NHL: either treatment naïve or relapsed or refractory following at least one prior treatment. 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.

2. Tumor 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
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 at least one highly effective or two effective contraceptive methods 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 highly effective contraception such as latex condom 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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 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
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
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 including egg
lecithin, and if enrolled in Part 2, anti-PD-1 antibodies
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 agents such as aspirin or clopidogrel should be
discussed with the Medical Monitor and may need to be discontinued before G100 therapy.
For patients enroll

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

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