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JBH492 for Leukemia and Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients with CLL: Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
For patients with NHL: Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL). Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 months
Awards & highlights
Study Summary
This trial assesses whether a new drug is safe and effective in humans.
Who is the study for?
This trial is for patients with confirmed chronic lymphocytic leukemia (CLL) or B- or T-cell non-Hodgkin's lymphoma (NHL). Participants must have a disease site suitable for biopsy and agree to undergo required biopsies. Exclusions include prior treatment with maytansine-based ADC, intolerance to maytansinoids, active CNS involvement unless effectively treated, impaired cardiac function, HIV/HBV/HCV infections not controlled by therapy, active/chronic corneal disorders, and severe hypersensitivity to ADCs/mAbs.Check my eligibility
What is being tested?
The study tests JBH492 as a single agent in its first use on humans. It aims to evaluate the drug's safety, tolerability, how it moves through and affects the body (pharmacokinetics), potential immune system reactions (immunogenicity), and initial effectiveness against CLL/NHL.See study design
What are the potential side effects?
While specific side effects of JBH492 are being studied in this trial and are not yet fully known due to its first-in-human status, common side effects from similar drugs include infusion reactions like fever or chills; organ inflammation; fatigue; digestive issues; blood disorders that can affect clotting or immunity; vision changes due to retinal problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic lymphocytic leukemia (CLL).
Select...
I have B- or T-cell non-Hodgkin's lymphoma and can undergo required biopsies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose intensity
Incidence and severity of Adverse Events (AEs)
Incidence and severity of Serious Adverse Events (SAEs)
+3 moreSecondary outcome measures
Best overall response (BOR)
Duration of Response (DOR)
Incidence of anti-JBH492 antibodies
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: JBH492 single agentExperimental Treatment1 Intervention
Patients with R/R CLL or NHL
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,680 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with chronic lymphocytic leukemia (CLL).I have been treated with a drug related to maytansine before.I have heart problems that affect my daily activities.I have B- or T-cell non-Hodgkin's lymphoma and can undergo required biopsies.I do not have active brain involvement from cancer, or it has been treated and stable for over 4 weeks.You have experienced bad reactions or side effects to a specific type of medication called a maytansinoid.I have an ongoing or recurrent eye condition affecting the cornea.I have had severe allergic reactions to certain cancer drugs or their ingredients.I have a condition that makes it hard to examine the back of my eye.I have hepatitis but it's under control with medication.I have been diagnosed with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: JBH492 single agent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results are investigators hoping to glean from this research?
"Over the course of 32 months, this medical trial will assess Serious Adverse Events (SAEs) as its primary objective. Among secondary aims are to evaluate Overall Response Rate (ORR), Time until Maximum Serum Drug Concentration (TMax), and Area Under Plasma Concentration-Time Curve from Zero to Last Measurable Sample Collection Time(AUClast)."
Answered by AI
Are there opportunities for people to join the trial currently?
"This medical study, which began enrolling participants on 7th September 2020, is currently open for recruitment according to information posted on clinicaltrials.gov. It was last updated in November 11th 2022."
Answered by AI
Has the FDA sanctioned JBH492 for use?
"Since this is a Phase 1 clinical trial, with limited data in regards to safety and efficacy, we here at Power have rated JBH492's safety as a 1 on the scale."
Answered by AI
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