A Phase 1 interventional study of JBH492 in Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia, sponsored by Novartis Pharmaceuticals. Terminated at 8 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
The purpose of the First-In-Human study was to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
This was a FIH, open-label, phase I/Ib, multi-center study, which consisted of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the maximum tolerated dose/recommended dose (MTD/RD) of single agent JBH492 was determined, the study continued with an expansion part with single agent JBH492 in defined patient populations.
1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.
This study's enrollment of 25 is below the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For patients with CLL:
For patients with NHL:
Exclusion Criteria, applicable to both CLL and NHL:
Other inclusion and exclusion criteria may apply.
Patients with R/R CLL or NHL
Drug: JBH492
Anti-CCR7 antibody-drug conjugate (ADC)
Incidence and severity of dose limiting toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that occurs during the first cycle of treatment with JBH492 and meets any of the protocol specified criteria, unless incontrovertibly related to underlying disease, intercurrent illness or concomitant medications.
Time frame: 32 months
Incidence and severity of Adverse Events (AEs)
An adverse event ( treatment emergent) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
Time frame: 32 months
Incidence and severity of Serious Adverse Events (SAEs)
A Serious adverse event (SAE) is defined as one of the following: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Is medically significant * Requires inpatient hospitalization or prolongation of existing hospitalization.
Time frame: 32 months
Number of patients with dose interruptions
Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions
Time frame: 32 months
Number of patients with dose reductions
Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions
Time frame: 32 months
Dose intensity
Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intensity
Time frame: 32 months
Overall response rate (ORR)
The overall response rate (ORR), defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), as per local review and according to the iwCLL guideline (CLL) or Lugano Classification (NHL).
Time frame: 32 months
Best overall response (BOR)
The best overall response (BOR) is the best reponse recorded in a patient from the start of treatment until disease progression.
Time frame: 32 months
Duration of Response (DOR)
The time between the date of first documented response (CR or PR) and the date of first documented progression or death due to underlying cancer.
Time frame: 32 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause
Time frame: 32 months
Pharmacokinetics (PK) parameter AUClast
The area under the plasma concentration-time curve (AUC) of JBH492 from time zero to the last measurable concentration sampling time (tlast) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
PK parameter AUCinf
The AUC from time zero to infinity (mass × time × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
PK parameter AUCtau
The AUC calculated to the end of a dosing interval (tau) (mass × time × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
PK parameter Cmax and Cmin
The maximum (peak) and minimum observed serum drug concentration (mass × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
PK parameter Tmax
The time to reach maximum (peak) serum drug concentration (time) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
PK parameter T1/2
The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)
Time frame: 32 months
Incidence of anti-JBH492 antibodies
Number of subjects with anti-JBH492 antibodies (Anti-Drug Antibodies)
Time frame: 32 months
Plan to share: No
This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals