Imviva Biotech CTD402 shows 80–86% response in R/R T-ALL at EHA2026
Imviva Biotech has reported clinical data from two poster presentations at the European Hematology Association 2026 Congress (EHA2026) in Stockholm, showing high complete remission rates for its allogeneic CAR-T candidate CTD402 in relapsed or refractory T-cell acute lymphoblastic leukaemia and lymphoblastic lymphoma (R/R T-ALL/LBL), a disease with few effective salvage options.
The data covered both a global Phase 1b/2 study in adults and a pooled analysis of Chinese academic-centre trials in adolescent and paediatric patients, collectively positioning CTD402 as a potential off-the-shelf therapy for one of the harder-to-treat haematological malignancies.
Adult cohort: TENACITY-01
Preliminary data from TENACITY-01, presented by Dr Lori Muffly of Stanford Medicine, covered seven adult patients who had received CTD402 at the recommended Phase 2 dose following standard lymphodepletion chemotherapy. As of 8 June 2026, the therapy produced an overall response rate of 85.7% and an overall complete remission rate of 71.4%, with 80% of those achieving complete remission also testing negative for minimal residual disease (MRD). The safety profile was broadly manageable: cytokine release syndrome of Grade 2 or below was observed in 86% of patients, and no cases of neurotoxicity syndrome or graft-versus-host disease were reported. CAR-T cell persistence beyond 28 days was recorded in 60% of patients.
"We're now seeing consistent efficacy with an 85.7% overall response rate and high rates of MRD-negative remissions, reinforcing the potential of this off-the-shelf therapy for patients with very limited treatment options," said Muffly.
Paediatric data and survival signal
In the second presentation, Dr Xian Zhang of Hebei Yanda Ludaopei Hospital reported pooled data from 15 adolescent and paediatric patients with a median age of 15, treated across five academic centres in China. CTD402 produced an 80% complete remission rate, with 83.3% of responders achieving MRD-negative status. Importantly, median overall survival had not been reached in patients who went on to receive consolidative allogeneic haematopoietic stem cell transplant, compared with 4.8 months in those who did not, a statistically significant difference (p=0.026). No neurotoxicity or severe infections were observed in this cohort.
CTD402 employs T-cell receptor and HLA class II knockout alongside Imviva's proprietary ANSWER inhibitory ligands, engineered to reduce host immune rejection without the need for patient-specific manufacturing. The FDA has granted the candidate both Rare Paediatric Disease Designation and Regenerative Medicine Advanced Therapy (RMAT) designation for R/R T-ALL.
Market and competitive context
Allogeneic, or "off-the-shelf", CAR-T development has attracted sustained investment as a potential answer to the logistical and time pressures of autologous manufacturing. Several companies, including Precision BioSciences and Allogene Therapeutics, have pursued allogeneic platforms across B-cell and T-cell malignancies, with mixed results in early trials. The T-ALL indication is particularly challenging because CD7-targeting risks eliminating healthy T-cells alongside malignant ones, requiring engineering solutions of the kind Imviva has built into CTD402.
The RMAT designation is meaningful commercially: it provides intensive FDA interaction and can support rolling review, potentially compressing the timeline to a Biologics Licence Application. With TENACITY-01 still enrolling globally, the current dataset remains small and the adult cohort of seven patients limits statistical confidence. Investors and clinicians will look for expanded patient numbers, longer follow-up, and durability data before drawing firm conclusions on CTD402's competitive position against both emerging allogeneic rivals and established autologous regimens used as bridge-to-transplant.