Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Conditions
Brief summary
A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL
Interventions
DRUGTORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
DRUGTORL-5-700 at MTD/RP2D
Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks
DRUGTORL-5-700 at MTD/RP2D in combination with another agent
Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent
Sponsors
TORL Biotherapeutics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * At least 1 measurable lesion per Lugano criteria. * Tumor tissue is available. * Adequate organ function
Exclusion criteria
* T-cell lymphoma * CLL or SL * Burkitt lymphoma and high-grade B-cell lymphoma * CNS involvement * Peripheral neuropathy \> Grade 2 * Uncontrolled medical conditions * Viral infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Recommended Phase 2 Dose (RP2D) | 21 days from the start of treatment | Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities |
| Evaluate the safety of TORL-5-700 as a monotherapy | though study completion, an average of 2.5 years | Assessment of adverse events according to NCI-CTCAE Version 5.0 |
| Assess the antitumor activity of TORL-5-700 as monotherapy | though study completion, an average of 2.5 years | Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria |
| Evaluate the safety of TORL-5-700 in combination with other agents | though study completion, an average of 2.5 years | Assessment of adverse events according to NCI-CTCAE Version 5.0 |
| Determine the Maximum Tolerated Dose (MTD) | 21 days from the start of treatment | Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of distribution of TORL-5-700 in combination with other agents | though end of study treatment, an average of 5 months | PK assessment |
| Immunogenicity of TORL-5-700 | though end of study treatment, an average of 5 months | Immunogenicity will be measured by incidence of treatment emergent ADAs |
| Immunogenicity of TORL-5-700 in combination with other agents | though end of study treatment, an average of 5 months | Immunogenicity will be measured by incidence of treatment emergent ADAs |
| Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents | though study completion, an average of 2.5 years | Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria |
| Maximum Serum Concentration of TORL-5-700 (Cmax) | though end of study treatment, an average of 5 months | Pk assessment |
| Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents | though end of study treatment, an average of 5 months | Pk assessment |
| Terminal Half-life (t1/2) of Serum TORL-5-700 | though end of study treatment, an average of 5 months | Pk assessment |
| Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration | though end of study treatment, an average of 5 months | Pk assessment |
| Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents | though end of study treatment, an average of 5 months | Pk assessment |
| Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents | though end of study treatment, an average of 5 months | Pk assessment |
| Clearance (CL) of TORL-5-700 | though end of study treatment, an average of 5 months | Pk assessment |
| Clearance (CL) of TORL-5-700 in combination with other agents | though end of study treatment, an average of 5 months | Pk assessment |
| Volume of distribution of TORL-5-700 | though end of study treatment, an average of 5 months | PK assessment |
Countries
United States
Contacts
CONTACTEric Park, M.D.
Outcome results
None listed