Imviva Reports High Response Rates for Off-the-Shelf CAR-T Therapy CTD402 in Relapsed or Refractory T-ALL/LBL

Imviva Biotech presented new clinical findings at the European Hematology Association (EHA) 2026 Congress highlighting the potential of CTD402, an investigational allogeneic anti-CD7 CAR-T cell therapy, in patients with relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma (T-ALL/LBL).¹

The data, presented in two posters, demonstrated encouraging response rates and a manageable safety profile in both pediatric and adult patient populations, supporting continued development of the company's off-the-shelf cellular therapy platform.¹

Relapsed or refractory T-ALL/LBL remains a particularly challenging disease to treat, with limited therapeutic options and poor outcomes for many patients whose disease progresses after standard treatment.²

How did CTD402 perform in adult patients?

Preliminary results from the ongoing global Phase 1b/2 TENACITY-01 study showed that six of seven treated patients responded to CTD402, resulting in an overall response rate of 85.7%.¹ Five patients achieved complete remission or complete remission with incomplete hematologic recovery, corresponding to a complete remission rate of 71.4%.¹

Among responders, 80% achieved measurable residual disease (MRD)-negative status, a key indicator associated with deeper remission and improved long-term outcomes in acute lymphoblastic leukemia.²

Investigators reported that the safety profile was manageable. Most cases of cytokine release syndrome were low grade, and no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease were observed.¹

What did the pediatric analysis show?

Researchers also reported pooled phase 1/2 findings from 15 adolescent and pediatric patients treated across five academic centers in China. Despite a heavily pretreated population with high-risk disease features, CTD402 produced complete remission in 80% of patients.¹

Among those achieving remission, 83.3% became MRD-negative. Investigators reported predominantly mild Grade 1 or 2 cytokine release syndrome and observed no neurotoxicity or severe infections.¹

At a median follow-up of nearly 22 months, median overall survival had not been reached among patients who received consolidative allogeneic hematopoietic stem cell transplantation after CAR-T therapy, compared with 4.8 months in patients who did not undergo transplant.¹

Why is interest growing in allogeneic CAR-T therapies?

While currently approved CAR-T therapies are primarily autologous products manufactured from a patient's own cells, allogeneic approaches use donor-derived cells that can be prepared in advance and stored for immediate use.³

This "off-the-shelf" model may help address manufacturing delays that can be particularly problematic for patients with rapidly progressing hematologic malignancies.³ CTD402 incorporates gene-editing strategies designed to reduce the risk of graft-versus-host disease and improve resistance to immune rejection, potentially enhancing the durability of treatment.¹

What could these findings mean for future development?

The results add to growing evidence supporting allogeneic CAR-T therapies as a potential next generation of cellular immunotherapy. While the datasets remain relatively small and longer follow-up will be needed to assess durability, the combination of high remission rates, MRD negativity, and favorable safety findings suggests CTD402 may offer a promising treatment option for patients with few alternatives.¹˒²

The therapy is currently being evaluated in the global TENACITY-01 trial (NCT07070219) and has received both Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA for relapsed or refractory T-cell acute lymphoblastic leukemia.¹

References

1. Imviva Biotech Presents Studies on CTD402 Allogeneic CAR-T Therapy at EHA2026 Congress. (2026 Jun 11). Globe Newswire. https://www.globenewswire.com/news-release/2026/06/11/3310460/0/en/imviva-biotech-presents-studies-on-ctd402-allogeneic-car-t-therapy-at-eha2026-congress.html
2. Hunger SP, Mullighan CG. (2015 Oct 15). Acute Lymphoblastic Leukemia in Children. N Engl J Med. https://www.nejm.org/doi/abs/10.1056/NEJMra1400972
3. Depil S, Duchateau P, Grupp SA, Mufti G, Poirot L. (2020 Mar). 'Off-the-shelf' allogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. https://pubmed.ncbi.nlm.nih.gov/31900462/