Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL) MedDRA version: 22.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Genmab Holding B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential subject must fulfill all of the following criteria to be enrolled in the trial. - Be at least 18 years of age. - Must sign an informed consent form (ICF) prior to any screening procedures. - Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy. - Has 1 of the following B-cell NHL subtypes for the Dose Escalation: o DLBCL, de novo or histologically transformed o HGBCL o PMBCL o FL, with advanced symptomatic disease and with a need for treatment o MCL, without leukemic manifestation o MZL, either nodal, extranodal or mucosa associated, with a need for treatment initiation based on symptoms and/or disease burden o SLL, with a need for treatment based on symptoms and/or disease burden o CLL, with B-cell count =65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the trial. - Prior treatment with a CD37-targeting agent. - Prior allogeneic hematopoietic stem cell transplantation (HSCT). - Autologous HSCT within 3 months before the first dose of GEN3009. - Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor-T (CAR-T) cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009. - Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009. - Treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy. - Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2–week period before the first dose of GEN3009. - Has uncontrolled intercurrent illness (refer to Protocol Section 5.2 for details). - Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy. - Primary central nervous system (CNS) lymphoma or known CNS involvement at screening. - Has known past or current malignancy other than inclusion diagnosis (refer to Section 5.2 for details). - Has had major surgery within 3 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009). - Has known history/positive serology for hepatitis B. - Known medical history or ongoing hepatitis C infection that has not been cured. - HIV tested positive at screening. - Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3009. - Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose Escalation: - Determine the MTD with and/or determine the RP2D - Evaluate safety and tolerability of GEN3009 Dose Expansion: -Evaluate (preliminary) anti-tumor efficacy;Secondary Objective: Dose Escalation: - Establish PK profile - Evaluate immunogenicity - Evaluate preliminary anti-tumor efficacy - Evaluate preliminary clinical efficacy Dose Expansion: -Establish PK profile - Evaluate safety and tolerability of GEN3009 - Evaluate clinical efficacy - Evaluate immunogenicity;Primary end point(s): Dose Escalation: • Rate of DLTs • Frequency and severity of AEs/SAEs • Changes in laboratory parameters • Changes in vital signs Dose Expansion: • ORR;Timepoint(s) of evaluation of this end point: During the trial, see protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Dose Escalation: • PK parameters: clearance, volume of distribution and area under the curve (AUC) at different time points (AUC7days, AUClast and AUCinf), maximum concentration (Cmax), time to Cmax (Tmax), predose trough concentrations (Ctrough), and half-life (T1/2) • Incidence of neutralizing anti-GEN3009 antibodies (ie, anti-drug antibodies [ADAs]) • Objective response rate (ORR) • Complete response rate (CR) • Duration of response (DoR) • Time to response (TTR) • Progression-free survival (PFS) • Overall survival (OS) Dose Expansion: - PK parameters: clearance, volume of distribution and AUC at different time points (AUC7days, AUClast and AUCinf), Cmax, Tmax, Ctrough, and half-life (T1/2) • Frequency and severity of AEs • Changes in laboratory parameters • Changes in vital signs • CR • DoR • TTR • PFS • OS Incidence of neutralizing anti-GEN3009 antibodies (ie, ADAs);Timepoint(s) of evaluation of this end point: During the trial, see protocol | — |
Countries
Belgium, Denmark, Netherlands, Spain, United States
Contacts
Public ContactClinical Trials Information
Genmab Holding B.V.
Outcome results
None listed