Ibrahim Aldoss, MD, of the division of hematology and stem cell transplant at Metropolis of Hope, discusses the promising section 2 outcomes of the section 1/2 WU-CART-007 (W-T7) 1001 trial, which demonstrated excessive efficacy and a manageable security profile for W-T7, an off-the-shelf, allogeneic, CD7-targeted chimeric antigen receptor (CAR) T-cell remedy, in sufferers with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).
Aldoss offered this information final month on the European Hematology Affiliation (EHA) 2024 Congress.
This transcript has been frivolously edited for readability.
Transcript
Might you focus on the design and goals of the Part 2 WU-CART-007 trial?
So, W-T7 1001 medical trial is a worldwide first in human section 1/2 single agent research of W-T7 in sufferers with relapsed/refractory T-cell ALL and lymphoblastic lymphoma [LBL]. There was a section 1 a part of the research, utilizing dose escalation for single infusion of the W-T7. There have been 4 dose ranges that have been accomplished and offered final 12 months at ASH [American Society of Hematology annual meeting]. Right here [at EHA 2024 Congress], I am presenting the growth cohort for the 1001 research that makes use of W-T7 on the advisable section 2 dosing after an enhanced lymphodepletion routine.
Might you summarize the important thing findings?
We noticed that W-T7 confirmed a manageable security profile. Remedy-related opposed occasions grade 3 or greater have been noticed in 61.5% of all sufferers. Now, nearly all of these treatment-related opposed occasions have been CRS [cytokine release symdrome], however the majority have been grade 1 and grade 2. Grade 3 was solely noticed in 3 sufferers and grade 4 in 2 sufferers; each grade 3 and 4 have been manageable with supportive care and fully resolved. We’ve got seen grade 1 ICANS [immune effector cell-associated neurotoxicity syndrome] in 2 sufferers, grade 2 HLH [hemophagocytic lymphohistiocytosis] in 2 sufferers, and grade 2 graft-versus-host illness in 1 affected person.
Now, extra vital is the exercise of the W-T7 on the advisable section 2 dosing. The general response price was 91%, very encouraging. The composite full remission was 73%, and the median period of remission was 6.2 months. We had 7 sufferers after response who have been in a position to obtain consolidation with allogeneic stem cell transplant, together with 5 sufferers handled on the advisable section 2 dosing.
These sufferers have been closely pretreated. The median variety of prior strains of remedy was 4 strains of remedy in sufferers handled in section 1, and it was 3 strains of remedy in sufferers handled within the section 2 portion of the research. Over a 3rd of the sufferers had prior allogeneic stem cell transplants, so these are closely pretreated sufferers with very restricted choices. We’re seeing a really encouraging response price with a manageable security profile.
How may future research construct on these findings to boost therapy outcomes for sufferers with R/R T-ALL/LBL?
With these encouraging outcomes, they’re really actively designing a registration research that can have 2 arms: 1 arm for relapsed/refractory illness and a second arm for sufferers with solely MRD [minimal residual disease] relapsed/refractory illness.
The research will enroll sufferers as younger as 1 12 months previous with relapsed/refractory T-cell ALL, in addition to lymphoblastic lymphoma [LBL]. The hope is, if these trials are profitable, that it’ll result in the FDA approval of the W-T7.
