First in Human Study of NVG-111 in Chronic Lymphocytic Leukaemia and Mantle Cell Lymphoma

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is the first clinical trial of the drug NVG-111, and will include patients with certain types of blood cancer called chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL). NVG-111 is a bispecific antibody drug, having two "arms", one arm attaches to a substance on cancer cells called ROR1, the other arm attaches to the body's immune cells directing them to kill the cancer cells.

The trial has two parts, the first part tests the safety of the drug at different dose levels. Once the first part of the study is complete a dose will be chosen for the second part of the study. The second part of the study will test how well NVG-111 works in treating these diseases.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovalGen Ltd.

Criteria

Inclusion criteria:

• Personally signed informed consent document

• Male or female, age ≥18 years

• Relapsed or refractory CLL/SLL or MCL:

• CLL/SLL patients on at least 2nd line therapy, with a partial response at Screening to ≥12 months ongoing treatment with Bruton's tyrosine kinase inhibitor (BTKi) or venetoclax ± anti-CD20 MAb

• MCL patients on at least 2nd line therapy, with a partial response at Screening to ≥6 months ongoing treatment with a BTKi

• MCL and SLL patients must have archived tumor biopsy tissue available, or have a new biopsy unless blood or bone marrow tests at Screening show detectable ROR1

• ECOG performance status ≤2

• Adequate organ function

• Bilirubin ≤1.5 x ULN (unless Gilbert's syndrome)

• AST and ALT ≤2.5 x ULN (if no hepatic CLL or MCL), or AST and ALT ≤5 x ULN (if hepatic CLL or MCL)

• APTT and PT ≤1.5 x ULN

• ANC ≥0.5 x 10^9 /L (without growth factors) and platelets ≥ 30 x 10^9 /L (without transfusion)

• Serum creatinine ≤2 x ULN

• Estimated creatinine clearance ≥30 mL/min

• In females of childbearing potential, a negative serum pregnancy test

• For both males and females, willingness to use adequate contraception

• Willingness and ability to comply with study procedures

Exclusion Criteria:

• Richter's transformation

• CNS or leptomeningeal lymphoma

• High tumour bulk as defined in the protocol

• Allogeneic or autologous hematopoietic stem cell transplant or donor lymphocyte infusion within prior 6 months.

• Uncontrolled autoimmune haemolytic anaemia or idiopathic thrombocytopenic purpura

• Clinically significant neurological disease

• Clinically significant cardiovascular disease or ECG abnormalities

• Severe chronic lung disease

• Positive test at Screening for Covid-19, HIV, hepatitis B or hepatitis C infection

• Presence of other major cancer

• Any other concurrent cancer treatments

• Recent or planned live vaccines

• Uncontrolled ongoing infection

• Recent major surgery

• Concurrent participation in another clinical trial, or experimental therapy within 5 half-lives of Screening

• Pregnant or currently breastfeeding.

• Any other medical condition that in the opinion of the investigator contraindicates participation in the study