Safety and Efficacy Study of Epcoritamab in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000848-57-BE
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
• Subject must sign an ICF, prior to any screening procedures
• Must be at least 18 years of age
• Must have active CLL disease that needs treatment per iwCLL2018 (refer to Section 5.1 for details).
• R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor (eg, ibrutinib); Relapse is defined as evidence of disease progression in a subject who has previously achieved a complete response (CR) or partial response (PR) for =6 months. Refractory disease is defined as treatment failure (not achieving a CR or PR) or as progression within 6 months from the last dose of therapy.
• Has Measurable Disease with at least one of the following criteria:
a. =5 × 109/L (5,000/µL) B lymphocytes in peripheral blood
b. Presence of measurable lymphadenopathy and/or organomegaly
• ECOG performance status score of 0 or 1
• Screening flow cytometry evidence of CD20 positivity
• Has acceptable laboratory parameters
• Subject must have availability of fresh bone marrow material at screening
• Must take prophylaxis for TLS
• A woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab.
• A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative serum or urine pregnancy test before treatment administration on Day 1 of Cycle 1
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after last treatment.
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21
• Transformation of CLL to aggressive non-Hodgkin lymphoma
• Subject received prior treatment with a CD3 × CD20 bispecific antibody.
• Subject received any prior allogeneic HSCT or solid organ transplantation
• Subject received treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or CAR T-cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of epcoritamab
• Subject received chemotherapy or radiation therapy within 2 weeks of the first dose of epcoritamab
• Subject received 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 epcoritamab.
• Subject has autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
• Subject has uncontrolled intercurrent illness
• Has a baseline QT interval at screening as corrected by Fridericia’s formula (QTcF) >480 msec
• Subject received vaccination with live vaccines within 28 days prior to the first dose of epcoritamab
• Subject has toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
• Subject has known central nervous system involvement at screening.
• Subject has suspected allergies, hypersensitivity, or intolerance to epcoritamab or its excipients (refer to the IB for more information).
• Subject is unable to tolerate uric acid reducing medications
• Has known history/positive serology for hepatitis B
• Known medical history or ongoing hepatitis C infection that has not been cured.
• Subject tests positive for HIV at screening.
• Subject 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 epcoritamab.
• Subject is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method