Brexucabtagene Autoleucel for B-Cell Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Elias Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anti-CD19 CAR T

Disqualifiers: Philadelphia positive, Pregnant, others

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have chronic viral infections like Hepatitis B, C, or HIV, you can participate if your infections are under control with therapy.

What data supports the effectiveness of the treatment Brexucabtagene Autoleucel for B-cell leukemia?

Brexucabtagene autoleucel has shown effectiveness in treating relapsed or refractory B-cell acute lymphoblastic leukemia, with a complete remission rate of 73% and a median overall survival of 25.4 months in a study with 78 patients. It has also been effective in treating mantle cell lymphoma, with a complete response rate of 68% in a clinical trial.

^{1 2 3 4 5}

Is Brexucabtagene Autoleucel safe for humans?

Brexucabtagene autoleucel, also known as KTE-X19 or brexu-cel, has been studied for safety in patients with B-cell acute lymphoblastic leukemia and mantle cell lymphoma. In these studies, it was generally well-tolerated, but like many treatments, it can have side effects, so it's important to discuss potential risks with your doctor.

^{1 2 3 4 5}

How is the treatment brexucabtagene autoleucel unique for B-cell leukemia?

Brexucabtagene autoleucel is a unique treatment for B-cell leukemia because it is a CAR T-cell therapy that uses the patient's own modified immune cells to target and destroy cancer cells. This approach is different from traditional chemotherapy or radiation, as it specifically targets the CD19 protein on cancer cells, offering a personalized and potentially more effective treatment option for those with relapsed or refractory B-cell acute lymphoblastic leukemia.

^{1 2 3 4 5}

Eligibility Criteria

This trial is for patients with B-cell Acute Lymphocytic Leukemia (ALL) who have either not responded to previous treatments or are newly diagnosed and at high risk. Participants must have completed treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD or mini-hyper-CVD.

Inclusion Criteria

My kidney and liver functions are within the required limits.

I am 18 or older with B-cell ALL that has come back or didn't respond to treatment.

My cancer cells are mostly CD19 positive.

Exclusion Criteria

I have previously received CAR T cell therapy targeting CD-19.

I cannot or do not want to sign the consent form.

My doctor thinks I have an active and uncontrolled disease or infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cytoreduction

Participants receive cytoreductive therapy with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD

4-6 weeks

Lymphodepletion and CAR-T Infusion

Participants undergo lymphodepletion chemotherapy followed by 1 dose of brexucabtagene autoleucel

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CAR-T-cell expansion and B-cell aplasia assessments

24 months

Monthly up to 3 months, then every 3 months up to 24 months

Participant Groups

The study is testing the safety and effectiveness of brexucabtagene autoleucel as a follow-up therapy in controlling B-cell ALL after initial treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD/mini-hyper-CVD regimens.

Group I: Phase 1B + Phase 2 Experimental Treatment 4 Interventions

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study. [2023] Brexucabtagene autoleucel (KTE-X19) is an autologous anti-CD19 CAR T-cell therapy approved in the USA to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (R/R B-ALL) based on ZUMA-3 study results. We report updated ZUMA-3 outcomes with longer follow-up and an extended data set along with contextualization of outcomes to historical standard of care.

2. United States pubmed.ncbi.nlm.nih.gov

Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study. [2023] Brexucabtagene autoleucel (KTE-X19) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy is approved for the treatment of relapsed/refractory mantle cell lymphoma (MCL). Outcomes after a 3-year follow-up in the pivotal ZUMA-2 study of KTE-X19 in relapsed/refractory MCL are reported, including for subgroups by prior therapy (bendamustine and type of Bruton tyrosine kinase inhibitor [BTKi]) or high-risk characteristics.

3. England pubmed.ncbi.nlm.nih.gov

Impact of prior therapies and subsequent transplantation on outcomes in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3. [2023] Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved in the USA for adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) and in the European Union for patients ≥26 years with R/R B-ALL. After 2 years of follow-up in ZUMA-3, the overall complete remission (CR) rate (CR+CR with incomplete hematological recovery (CRi)) was 73%, and the median overall survival (OS) was 25.4 months in 78 Phase 1 and 2 patients with R/R B-ALL who received the pivotal dose of brexu-cel. Outcomes by prior therapies and subsequent allogeneic stem cell transplantation (alloSCT) are reported.

4. United States pubmed.ncbi.nlm.nih.gov

Brexucabtagene Autoleucel: A Novel Chimeric Antigen Receptor T-cell Therapy for the Treatment of Mantle Cell Lymphoma. [2022] To identify and assess the current literature surrounding the safety, efficacy, and practical considerations of brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (MCL).

5. United States pubmed.ncbi.nlm.nih.gov

Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma in Standard-of-Care Practice: Results From the US Lymphoma CAR T Consortium. [2023] Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). This therapy was approved on the basis of the single-arm phase II ZUMA-2 trial, which showed best overall and complete response rates of 91% and 68%, respectively. We report clinical outcomes with brexu-cel in the standard-of-care setting for the approved indication.