Using Brexucabtagene Autoleucel to treat B-cell Acute Lymphoblastic Leukemia after initial therapy
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
This study is testing a new CAR-T cell therapy called brexucabtagene autoleucel to see if it can help people with B-cell acute lymphoblastic leukemia who haven't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | CAR T, inotuzumab, blinatumomab, CAR-T, chimeric antigen receptor |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06287229 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of brexucabtagene autoleucel, a CAR-T cell therapy, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) following treatment with inotuzumab ozogamicin and blinatumomab. The study aims to determine the event-free survival (EFS) rates and overall survival (OS) at various time points for both relapsed and newly diagnosed high-risk patients. Participants will be monitored for safety, response rates, and measurable residual disease (MRD) negativity. The trial includes both primary and exploratory objectives to assess the treatment's impact on disease control and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory B-cell ALL or high-risk newly diagnosed B-cell ALL.
Not a fit: Patients with Philadelphia positive B-cell ALL or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve disease control and survival rates for patients with B-cell ALL.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elias Jabbour, MD — M.D. Anderson Cancer Center
- Study coordinator: Elias Jabbour, MD
- Email: ejabbour@mdanderson.org
- Phone: (713) 792-4764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.