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

TG Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma

Treatments: Drug: TG-1701; Biological: Ublituximab; Drug: Umbralisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03671590

TG-1701-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 3 patient groups

Arm 1: TG-1701 Monotherapy

Experimental group

Description:

Participants will receive TG-1701 oral daily dose. As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.

Treatment:

Drug: TG-1701

Arm 2: TG-1701 + Ublituximab + Umbralisib

Experimental group

Description:

Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.

Treatment:

Drug: Umbralisib

Biological: Ublituximab

Drug: TG-1701

Arm 3: Long Term Safety Extension - TG-1701 Monotherapy

Experimental group

Description:

All the ongoing participants from Arm 1 and 2, will be transitioned to TG-1701 monotherapy in long-term extension period, per protocol version 6.0.

Treatment:

Drug: TG-1701