NCT05464836

Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL

A Phase II Study to Evaluate Safety and Efficacy of CB-103 in Combination With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of 2 study drugs, CB-103 and venetoclax, can help to control T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic leukemia (T-LBL) in adolescent and young adult patients

Detailed description

Primary Objectives: * To characterize the safety and tolerability of CB-103 in combination with Venetoclax in adolescent (12 to 18 years) and adult (19 to 60 years) patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). * To assess the efficacy of CB-103 in combination with venetoclax by the overall response rate (ORR), defined as complete remission (CR), plus CR with incomplete blood count recovery (CRi) \[1\] plus partial remission (PR) \[2\], in adolescent, and young adult patients with relapsed/refractory T-ALL/T-LBL. Secondary Objectives: * To assess whether the ORR to CB-103 in combination with Venetoclax is dependent on pre-treatment expression of Notch and/or BCL2 pathway. * To determine the preliminary assessment of CB-103 in combination with Venetoclax by other efficacy parameters such as minimal residual disease (MRD), duration of response (DoR), overall survival (OS) and event-free survival (EFS) in adolescent and young adult patients with relapsed/refractory T-ALL/T-LBL. Exploratory Objectives: * To explore potential correlations of ORR to treatment and additional pharmacodynamic (PD) markers, i.e., other oncogenic pathway activations that may co-occur at the start of treatment. * To evaluate how many patients are able to transition to Hematopoietic Stem Cell Transplant (HSCT): * Either in the patients achieving CR after the induction and reinduction cycles; * Or in the patients with PR or stable disease (SD) after the induction and reinduction.

Conditions

• Leukemia, Lymphoblastic
• Leukemia

Interventions

Type	Name	Description
DRUG	CB-103	Given by PO
DRUG	Venetoclax	Given by PO

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2022-07-19
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study