All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know ALL.

The ALL Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your ALL Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The ALL Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the ALL Hub cannot guarantee the accuracy of translated content. The ALL Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2024-09-24T08:38:14.000Z

Tumor burden-guided dosing of obe-cel in patients with R/R B-cell ALL: Results from the FELIX trial

Sep 24, 2024
Share:
Learning objective: After reading this article, learners will be able to cite a new clinical development in acute lymphoblastic leukemia.

The phase Ib/II FELIX trial (NCT04404660) evaluated the safety and efficacy of obe-cel, a novel autologous CD19 CAR T-cell therapy, in 127 adult patients with R/R B-ALL.1 Patients received obe-cel based on a TB-guided dosing schedule. Results from this trial were presented at the SOHO 2024 Annual Meeting by Elias Jabbour.1

Key learnings

High CAR T-cell expansion was observed, with median peak expansion achieved after Dose 2 in both low- and high-TB-guided groups, demonstrating the beneficial effects of these doses independent of TB.  

The ORR was 78.0%, 73.3%, and 84.6% in all patients, high-TB patients (n=75), and low-TB patients (n=52), respectively. CR rates were 57.5%, 56.0%, and 59.6%, respectively.  

TB-guided dosing of obe-cel was associated with a manageable safety profile, including in high-TB patients. Obe-cel-related Grade ≥3 AEs were reported in 60.6% of all patients, 57.3% of high-TB patients, and 65.4% of low-TB patients. Grade ≥3 CRS occurred in 2.4%, 2.7%, and 1.9%, while ICANS occurred in 7.1%, 9.3%, and 3.8% of all patients, high-TB patients, and low-TB patients, respectively.  

The TB-guided administration of obe-cel resulted in promising efficacy and low incidences of Grade ≥3 immunotoxicity, supporting its use in patients with R/R B-ALL. 


Abbreviations: AE, adverse event; B-ALL, B-cell acute lymphoblastic leukemia; CAR, chimeric antigen receptor; CR, complete remission; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity; obe-cel, obecabtagene autoleucel; ORR, overall response rate; R/R, relapsed/refractory; SOHO, Society of Hematologic Oncology; TB, tumor burden. 


  1. Jabbour E. Obecabtagene autoleucel (obe-cel) for relapsed/refractory adult B-Cell acute lymphoblastic leukemia (R/R B-ALL): Impact of chimeric antigen receptor T-Cell (CAR T) and tumor burden-guided dosing in the FELIX phase 1b/2 study. Poster #ALL-502. Society of Hematologic Oncology (SOHO) 2024 Annual Meeting; Sep 4-7, 2024; Houston, US.  

Newsletter

Subscribe to get the best content related to ALL delivered to your inbox