Safety and tolerability of XmAb®13676 in Haematological malignancies
Research type
Research Study
Full title
A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb®13676 in Patients with CD20-Expressing Hematologic Malignancies
IRAS ID
288284
Contact name
Sunil Iyengar
Contact email
Sponsor organisation
Xencor, Inc
Eudract number
2017-001686-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 17 days
Research summary
This is a Phase 1, multiple-dose dose-escalation study to define a safe initial “priming dose” and a maximal tolerated dose and schedule, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess potential anti-tumour activity of XmAb13676 in patients with relapsed or refractory B-cell malignancies. There are a number of approved monospecific anti-CD20 antibodies. Considerable experience has been gained with them, and both efficacy and acceptable safety have been confirmed. However, it is expected that the efficacy will be greater and safety profiles will be markedly different with XmAb13676.
XmAb13676 is a humanised bispecific monoclonal antibody that binds both CD3 and the tumour antigen CD20 in order to recruit cytotoxic T cells to kill CD20 tumour cells. XmAb13676 has been designed to enable the design of stable molecules with favorable in vivo half-life, and to allow for the use of standard antibody production
methods.
Adult patients diagnosed with Non-CLL B-cell malignancy and CLL/SLL who have exhausted standard therapeutic options and have relapsed or refractory disease will be considered for the study.
This study will enroll two parallel Disease Groups of patients: dosing cohorts that establish a priming dose and Maximum Tolerated Dose(MTD) or Recommended Dose (RD) and schedule in patients with non-CLL B-cell malignancies (Group NHL [Non-Hodgkins Lymphoma]); and dosing cohorts that establish a priming dose and MTD/RD and schedule for patients with CLL/SLL (Group CLL). Patients will receive two 4-week cycles of therapy (8 doses); a patient may continue ontherapy past 2 cycles if, in the opinion of the investigator, he/she is deriving benefit and does not require additional non-study therapy.
Please note patients in the UK will only be enrolled in parts B,C and the expansion phase of the study.REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0063
Date of REC Opinion
8 Feb 2021
REC opinion
Favourable Opinion