NCT06287229

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.

Detailed description

Primary Objectives: To assess the Efficacy of Brexucabtagene autoleucel \[anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)\] in terms of EFS in patients with R/R and high-risk newly diagnosed B-cell acute lymphoblastic leukemia (B-cell ALL) post cytoreduction with mini-hyper-CVD-inotuzumab-blinatumomab/Hyper-CVAD-inotuzumab-blinatumomab The EFS will be estimated in terms of median EFS and 9-month EFS for the R/R cohort and 18-month EFS for the frontline cohort. Secondary Objectives: 1. 12 and 24-months overall survival (OS): 12 months for the R/R cohort and 24 months for the frontline cohort 2. Duration of persistent MRD negativity by flow cytometry and NGS at 9 and 18 months: 9 months for the R/R cohort and 18 months for the frontline cohort 3. Best Ooverall response rates \[complete remission (CR) and CR with incomplete count recovery (CRi)\] 4. Achievement of MRD negativity amongst patients in CR and not MRD negative before Brexucabtagene autoleucel infusion 5. Safety Exploratory Objectives: 1. CAR-T-cell expansion ((Days 1, 4, 8, 11, 14, 21, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion) 2. B-cell aplasia (Days 0, 7, 14, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion) 3. Measurable residual disease (MRD) negativity by next-generation sequencing (NGS) (at 1 in 105-6 sensitivity) (PB on D14 and PB/BM: Day 28, and then Q3 months up to 24 months post infusion) 4. Cytokine panel (Days 0, 1, 2, 4, 7, 10, 14, 28) 5. Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline, D28 and Q3 months. These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells.

Conditions

• Relapsed/Refractory
• B-cell Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Given by Infusion
DRUG	Inotuzumab Ozogamicin	Given by IV
DRUG	Hyper-CVAD	Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.
DRUG	Mini-hyper-CVD	Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD

Timeline

• Start date: 2024-07-11
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2024-03-01
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study