Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.

This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.

Inclusion Criteria:

• Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
• Adequate organ function

Exclusion Criteria:

• Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Known hepatitis B virus, hepatitis C virus or HIV infection