NCT05588440

A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies

Phase 1/2 Multi-Center Study to Evaluate the Safety and Efficacy of ONCT-808 in Adult Subjects With Relapsed or Refractory Aggressive B-Cell Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Oncternal Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study to investigate the safety and efficacy of the CAR-T therapy, ONCT-808, in patients with relapsed/refractory (R/R) aggressive B cell malignancies.

Detailed description

Study ONCT-808-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and anti-tumor activity of ONCT-808 in subjects with aggressive B cell lymphoma (BCL), including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). The study will be separated into two distinct phases designated as Phase 1 and Phase 2. After the safety and tolerability of ONCT-808 have been assessed to select the recommended Phase 2 dose (RP2D) in Phase 1, Phase 2 will commence to further validate the dose and evaluate the safety and efficacy of ONCT-808. In Phase 2, subjects with LBCL or MCL will be enrolled into 2 separate dose expansion cohorts.

Conditions

• Relapsed/Refractory Aggressive B-Cell Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	ONCT-808	A single infusion of ONCT-808 autologous CAR-T cell infusion will be administered intravenously Phase 1: Dose Escalation with bridging therapy as needed Phase 2: Patients with LBCL or MCL will be enrolled into two separate dose expansion cohorts.
DRUG	Bridging Therapy	Bridging therapy can be oral chemotherapy or IV radiotherapy/chemotherapy per institution's guidelines

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-09-12
• Completion: 2024-09-12
• First posted: 2022-10-20
• Last updated: 2024-12-05
• Results posted: 2024-12-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study