Published

April 2, 2025

Brexucabtagene autoleucel [BREX01a]

Brexucabtagene autoleucel modified CAR- T cells for treating relapsed/refractory Philadelphia negative or positive B cell precursor acute lymphoblastic leukaemia in patients aged 26 years and older where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (BREX01b) can only be completed as a continuation of this first part of the form (BREX01a) and BREX01b must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of brexucabtagene autoleucel

  1. This application is being made by and that leucapheresis for and treatment with brexucabtagene autoleucel-modified CAR-T cells will be initiated by a consultant haematologist specifically trained and accredited in the use of systemic anti-cancer therapy and working in an accredited CAR-T cell treatment centre and who is a member of the National CAR-T Clinical Panel for adult acute lymphoblastic leukaemia and a member of the treating Trust’s adult acute lymphoblastic leukaemia and CAR-T cell multidisciplinary teams.
  2. The patient has CD19 positive relapsed or refractory B lineage acute lymphoblastic leukaemia (ALL). Please tick appropriate box as to which type of ALL the patient has:
  • Philadelphia chromosome negative ALL or
  • Philadelphia chromosome positive ALL previously treated with at least 1 tyrosine kinase inhibitor (TKI) or the patient is unsuitable for or intolerant of TKI therapy Note: patients with Burkitt leukaemia/lymphoma or with chronic myeloid leukaemia lymphoid blast crisis are not eligible for treatment with brexucabtagene autoleucel.
  1. The patient fulfils one of the following clinical scenarios relating to the definition of relapsed or refractory ALL. Please tick the most appropriate box as to which applies to this patient:
  • the patient has primary refractory disease i.e. did not achieve a complete remission after 2 cycles of combination systemic anti-cancer therapy for newly diagnosed ALL or
  • the patient has a bone marrow relapse after allogeneic stem cell transplantation in 1st remission and is at least 3 months since allogeneic SCT with no active Graft versus Host Disease (GVHD) requiring systemic therapy or
  • the patient has a bone marrow relapse after allogeneic stem cell transplantation in 2nd remission or beyond, and is at least 3 months since allogeneic SCT with no GvHD requiring systemic therapy or
  • the patient is in 1st bone marrow relapse following a remission lasting 12 months or less (not had SCT) or
  • the patient is refractory to or has relapsed after 2nd or more lines of systemic anti-cancer therapy (not had SCT) or
  • relapsed disease and ineligible for allogeneic SCT due to comorbid disease (but still fit enough for CAR-T cell therapy with brexucabtagene autoleucel) or contraindicated to allogeneic SCT conditioning or lack suitable donor
  1. Having fulfilled, and ticked one of the criteria in box 3 above, the patient at the time of demonstration of such refractory/relapsed disease and thus consideration for potential treatment with brexucabtagene autoleucel has a bone marrow with CD19+ B-ALL demonstrable by flow cytometry. Measurable residual disease by molecular methods is insufficient to comply with access to brexucabtagene autoleucel.
  2. The patient does not have an isolated extramedullary ALL relapse i.e. if the patient has extramedullary disease, then the patient must also have bone marrow disease as set out above in criterion 4.
  3. At the time of this application for treatment with brexucabtagene autoleucel the patient does not have active CNS involvement by ALL whether this be CNS2 with neurological changes or CNS3.
  4. Whether the patient has been previously treated with blinatumomab or not. If there has been previous therapy with blinatumomab, there must be CD19 expression on the lymphoblasts (bone marrow or blood) after the most recent line of treatment. Please tick appropriate box as to whether the patient has received blinatumomab or not:
  • No previous treatment with blinatumomab or
  • Yes, previous treatment with blinatumomab
  1. Whether the patient has been previously treated with inotuzumab or not. Please tick appropriate box as to whether patient has received inotuzumab or not:
  • No previous treatment with inotuzumab or
  • Yes, previous treatment with inotuzumab
  1. The patient has either had no previous therapy with any genetically modified autologous or allogeneic T cell immunotherapy or the patient has been treated with doses of genetically modified autologous or allogeneic T cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial. Please tick appropriate box as to which type of previous treatment the patient has had:
  • No previous therapy with any genetically modified autologous or allogeneic T cell immunotherapy or
  • Previously treated with doses of genetically modified autologous or allogeneic T cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial.
  1. The patient has an ECOG performance status of 0 or 1.
  2. The patient has sufficient end organ function to tolerate treatment with brexucabtagene autoleucel.
  3. The patient is aged 26 years or more on the date of approval for brexucabtagene autoleucel by the National CAR-T Adult ALL Clinical Panel.
  4. Whether the current intent is for the patient to receive bridging therapy prior to the conditioning chemotherapy before CAR-T infusion. Please mark in the box below:
  • no, there is no current intent for the patient to undergo bridging systemic anti-cancer therapy or
  • yes, there is an intent for the patient to undergo bridging systemic anti-cancer therapy
  1. Prior to infusion 2 doses of tocilizumab are available for use in this patient in the event of the development of cytokine release syndrome.
  2. Brexucabtagene autoleucel-modified CAR-T cells will otherwise be used as set out in its Summary of Product Characteristics (SPC).
  3. approval for the use of brexucabtagene autoleucel has been formally given by the National adult acute lymphoblastic leukaemia CAR-T cell Clinical Panel. Please state date of approval (box DD/MM/YY)
  4. Following national approval for use of brexucabtagene autoleucel there has been local CAR-T cell multidisciplinary team agreement that this patient continues to have the necessary fitness for treatment and fulfils all the treatment criteria listed here.

CDF funded From: 27 April 2023

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CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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Note

The data on this page was produced using version 1.357 of the CDF list, downloaded from an archive of NHS England’s website on 02 April 2025 at 14:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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