Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This study will evaluate the safety and efficacy of 1A46 in adult patients with advanced CD20 and/or CD19 positive B-cell non-Hodgkin's lymphoma (NHL) or acute lymphoblastic leukemia (ALL).
Eligible Conditions
- Non-Hodgkin's Lymphoma (Disorder)
- Acute Lymphoid Leukemia, Disease (Disorder)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: From Baseline up to end of study or discontinuation due to disease progression, up to 5 years
Day 28
Escalation: Incidence of Adverse Events
Year 1
Escalation: Area Under the Concentration-Time Curve (AUC) from Time 0 to t
Escalation: Area under the serum concentration-time curve from time 0 to infinity (AUCinf)
Escalation: Maximum observed concentration (Cmax)
Escalation: Terminal disposition phase half-life(t1/2)
Escalation: Time to reach Cmax (Tmax)
Escalation: Total clearance after IV administration (CL)
Day 28
Escalation: Dose liming toxicity (DLT)
Year 5
Escalation: Anti-drug antibody (ADA)
Escalation: Disease control rate (DCR)
Escalation: Objective Response Rate (ORR)
Escalation: Overall survival (OS)
Escalation: Progression free survival (PFS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Dose Escalation
1 of 1
Experimental Treatment
165 Total Participants · 1 Treatment Group
Primary Treatment: Dose Escalation · No Placebo Group · Phase 1 & 2
Dose Escalation
Drug
Experimental Group · 1 Intervention: 1A46 Injection · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to end of study or discontinuation due to disease progression, up to 5 years
Closest Location: Norton Cancer Institute · Louisville, KY
2013First Recorded Clinical Trial
1 TrialsResearching Non-Hodgkin's Lymphoma (Disorder)
60 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have previously received R-CHOP, R-EPOCH or equivalent anti-CD20 containing therapy.
You have received or are ineligible for ASCT.
You have received or been intolerant of all other standard therapies thought to confer clinical benefit.
You have received or been intolerant of all other standard therapies thought to confer clinical benefit.
You have had 2 or more lines of systemic therapy.
Patients with aggressive NHL must have had at least one chemotherapy regimen.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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