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RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 24 months
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of brexucabtagene autoleucel and whether it helps control B-cell ALL, a blood cancer, after other cancer treatments. It is for adults whose cancer came back or did not respond to treatment, or whose newly diagnosed cancer has high-risk gene changes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older with B-cell ALL that came back, did not respond to treatment, or is newly diagnosed and high-risk.
  • For newly diagnosed cancer, high-risk changes must include KMT2A rearrangement, complex chromosome changes, low-hypodiploidy/tetraploidy (unusual chromosome numbers), or Philadelphia-like ALL.
  • Able to do daily self-care and be out of bed or a chair for at least half the day.
  • Kidney and liver blood tests must meet study limits: creatinine at most 1.6 mg/dl, bilirubin at most 3.5 mg, and ALT and AST at most 5 times the lab's normal upper limit.
  • More than 50% of cancer cells must have the CD19 marker before joining.
  • People with hepatitis B, hepatitis C, or HIV may join if they are receiving treatment and the infection is under control.

Who can't join

  • Philadelphia-positive B-cell ALL, a type with a specific gene change.
  • Pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test.
  • Past treatment with brexucabtagene autoleucel or another CAR T-cell treatment targeting CD19.
  • An active, uncontrolled illness or infection, as judged by the treating doctor.
  • Unable or unwilling to sign the consent form.
  • Use of another experimental treatment within the past 14 days.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

TX