QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With … (NCT03169790) | Clinical Trial Compass
WithdrawnPhase 1/2
QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL
Stopped: Trial not initiated
0Started 2017-12
Plain-language summary
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years.
. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
. Histologically confirmed relapsed CD20-positive NHL with progression on or within 6 months after rituximab therapy.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
. Have at least 1 measurable lesion of ≥ 1.5 cm.
. Must have a recent tumor biopsy specimen obtained following the conclusion of the most recent anti-cancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
. Must be willing to provide blood samples, and, if considered safe by the Investigator, a tumor biopsy specimen at 8 weeks after the start of treatment.
. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Exclusion criteria
. History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity resulting from previous therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Timeframe: 1 year
2
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
. Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL).
. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.