Clinical trial · Interventional
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
NCT06287229CI-TRIAL-00121167recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphocytic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Relapsed/Refractory | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| Hyper-CVAD | Drug | HyperCVAD Regimen | ALIAS |
| Inotuzumab Ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
| Mini-hyper-CVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1B + Phase 2
- description
- Participants found to be eligible to take part in this study, you will be assigned to a study phase (Phase 1B or Phase 2). Up to 10 participants will be enrolled in Phase 1B, and up to 30 will be enrolled in Phase 2. All participants will first receive cytoreductive therapy (inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD), followed by lymphodepletion chemotherapy and 1 dose of brexucabtagene autoleucel.
- interventionNames
- Drug: Blinatumomab
- Drug: Inotuzumab Ozogamicin
- Drug: Hyper-CVAD
- Drug: Mini-hyper-CVD
Primary outcomes (1)
- measure
- Safety and adverse events (AEs)
- timeFrame
- Through study completion; an average of 1 year
- description
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants of age ≥18 years with documented relapsed or refractory B-cell ALL * In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as: 1. KMT2A rearranged ALL 2. Complex cytogenetics as per NCCN 2022 3. Low-hypodiploidy/tetraploidy 4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions) * Performance status of 0, 1, or 2 * Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal * Participants should be CD19 expression positive (\>50%) before enrollment * Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control. Exclusion Criteria * Philadelphia positive B-cell ALL * Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization * Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy * Active and uncontrolled disease/infection as judged by the treating physician * Unable or unwilling to sign the consent form * No other investigational therapy within the past 14 days
References
Publications (1)
- DERIVEDDavis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463