Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-01-01 @ 4:25 PM
Study NCT ID:
NCT07053059
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.
Detailed Description:
Primary Objectives To assess the Efficacy of Obecabtagene autoleucel \[anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)\] in terms of EFS in patients with newly diagnosed high-risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Secondary Objectives:
1. 24-month overall survival (OS)
2. For Ph-negative B-cell ALL: Rate of persistent MRD negativity by flow cytometry and NGS at 18 months
3. For Ph-positive B-cell ALL: Rate of persistent MRD negativity by flow cytometry, NGS and BCR::ABL1 qPCR (CMR) at 18 months
4. Achievement of BCR::ABL1 complete molecular response (CMR) in patients with Ph-positive ALL having persistent measurable disease at any level before obe-cel infusion
5. Achievement of NGS MRD negativity amongst patients in CR and not MRD negative before obe-cel
6. Time to initiation of next anti-leukemia therapy except HSCT when done in ongoing continued morphological response (patients who did not start next anti-leukemia therapy except HSCT will be censored at the last follow-up/death).
7. Rates of HSCT in morphologic remission after obe-cel infusion
8. Safety
Exploratory Objectives:
1. CAR-T-cell expansion by digital droplet PCR (ddPCR) assay by a manufacturer designated central laboratory (CellCarta) on Days 7, 14, 21, 28, 3 months and then every 3 months up to 12 months post infusion. This will be a send-out test.
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 to study cytokine profile including IL1, IL6, IFNG, TNFalpha from infusion (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 from infusion. 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.
risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Secondary Objectives:
1. 24-month overall survival (OS)
2. For Ph-negative B-cell ALL: Rate of persistent MRD negativity by flow cytometry and NGS at 18 months
3. For Ph-positive B-cell ALL: Rate of persistent MRD negativity by flow cytometry, NGS and BCR::ABL1 qPCR (CMR) at 18 months
4. Achievement of BCR::ABL1 complete molecular response (CMR) in patients with Ph-positive ALL having persistent measurable disease at any level before obe-cel infusion
5. Achievement of NGS MRD negativity amongst patients in CR and not MRD negative before obe-cel
6. Time to initiation of next anti-leukemia therapy except HSCT when done in ongoing continued morphological response (patients who did not start next anti-leukemia therapy except HSCT will be censored at the last follow-up/death).
7. Rates of HSCT in morphologic remission after obe-cel infusion
8. Safety
Exploratory Objectives:
1. CAR-T-cell expansion by digital droplet PCR (ddPCR) assay by a manufacturer designated central laboratory (CellCarta) on Days 7, 14, 21, 28, 3 months and then every 3 months up to 12 months post infusion. This will be a send-out test.
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 to study cytokine profile including IL1, IL6, IFNG, TNFalpha from infusion (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 from infusion. 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.
risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-04660 | OTHER | NCI-CTRP Clinical Trials Registry | View |