A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma

TORL Biotherapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Treatments: Drug: TORL-5-700 at MTD/RP2D in combination with another agent; Drug: TORL-5-700; Drug: TORL-5-700 at MTD/RP2D

Study type: Interventional

Funder types: Industry

Identifiers

NCT07439653

TORL5700-001

Details and patient eligibility

About

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

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Part 1: Monotherapy Dose Escalation

Experimental group

Description:

TORL-5-700 Administered once every three weeks

Treatment:

Drug: TORL-5-700

Part 2: Monotherapy Expansion

Experimental group

Description:

TORL-5-700 at MTD/RP2D Administered once every three weeks

Treatment:

Drug: TORL-5-700 at MTD/RP2D

Part 3: Combination Evaluation

Experimental group

Description:

TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent

Treatment:

Drug: TORL-5-700 at MTD/RP2D in combination with another agent