Pooled Phase 1/2 data show 80% complete remission rate in pediatric R/R T-ALL/LBL patients
Global TENACITY-01 study reports 86% overall response rate in adults with R/R T-ALL/LBL
BOSTON, June 11, 2026 (GLOBE NEWSWIRE) — Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced new research findings at the European Hematology Association 2026 Congress (EHA2026), June 11-14, in Stockholm, Sweden. Shared in two poster presentations, the data demonstrated encouraging safety and efficacy results in both adult and pediatric patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (R/R T-ALL/LBL), a disease with limited treatment options and poor prognosis.
Patients with R/R T-ALL/LBL face substantial treatment challenges due to paucity and limited efficacy of available therapies. Findings presented at EHA2026 highlight the value of CTD402 as an “off-the-shelf”, point-of-care-ready CAR-T cell therapy for heavily pretreated pediatric and adult patients.
TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL)
In a second poster presentation delivered by Dr. Lori Muffly of Stanford Medicine, preliminary data from TENACITY-01, a global Phase 1b/2 study of CTD402, was featured. As of June 8th, 2026, seven patients with R/R T-ALL/LBL received CTD402 at the recommended phase 2 dose following standard lymphodepletion chemotherapy. The therapy demonstrated an overall response rate of 85.7% (6/7 patients) and an overall complete remission (CRc = CR + CRi) rate of 71.4% (5/7 patients), with 80% (4/5) achieving MRD-negative status.
The safety profile has been manageable, with low-grade (<=G2) cytokine release syndrome observed in 86% of patients and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome observed in 29% of patients. Notably, no cases of immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were reported. CTD402 demonstrated robust pharmacokinetics with peak expansion at Day 10 and persistence beyond 28 days in 60% of patients. One highlighted case involved a heavily pretreated patient with 90% bone marrow blasts and extensive extramedullary disease who achieved complete remission with incomplete hematologic recovery and successfully transitioned to allogeneic hematopoietic stem cell transplant, continuing in remission thereafter.
“These results from TENACITY-01 validate our earlier CTD402 findings in a global setting,” said Lori Muffly, MD, MS, of Stanford Medicine. “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.”
CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL
In a poster presentation delivered by Dr. Xian Zhang of Hebei Yanda Ludaopei Hospital, researchers analyzed pooled safety and efficacy data from multiple Phase 1/2 studies, conducted across five academic centers in China, evaluating CTD402 in 15 adolescent and pediatric patients with a median age of 15 years (range 10-17). Despite treating a challenging patient population who had received a median of two prior lines of therapy (range 1-5), with 26.7% having primary refractory disease, 60% with extramedullary disease, and 60% with high-risk molecular features, the therapy demonstrated an impressive 80% complete remission rate (12/15 patients), with 83.3% of responders (10/12) achieving MRD-negative status.
The safety profile was favorable, with 66.7% experiencing predominantly mild Grade 1-2 CRS and notably no neurotoxicity or severe infections observed. CAR-T cells persisted for at least 28 days in 66.7% of patients, with some showing persistence up to 90-180 days, and at a median follow-up of 21.94 months, median overall survival was not reached in patients who received consolidative allogeneic transplant, compared with 4.8 months in non-transplant patients (p=0.026), highlighting the potential benefit of post-CAR-T consolidation strategies.
“These encouraging results from our pediatric cohort underscore CTD402’s potential to transform care for patients with R/R T-ALL/LBL,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. “The combination of strong efficacy—with 80% of pediatric patients achieving complete remission—and a favorable safety profile, alongside CTD402’s immediate availability as an off-the-shelf therapy, demonstrates the potential to address a critical unmet need in this patient population.”
Abstracts are currently available to the public at: https://library.ehaweb.org/eha/#!*menu=6*browseby=3*sortby=2*ce_id=2934.
For more information, visit www.imvivabio.com.
About CTD402
CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER™ inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.
A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).
About Imviva Biotech
Imviva Biotech is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company’s proprietary platform incorporates advanced cell engineering technologies to create off-the-shelf cellular immunotherapies. Imviva’s pipeline includes programs in both oncology and autoimmune indications.
Forward-Looking Statements
This press release contains forward-looking statements regarding product development and potential. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.
Contacts:
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Stephanie Carrington
ICR Healthcare
ImvivaBiotechIR@icrhealthcare.com
(646) 277-1282
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Ally Stubin
ICR Healthcare
ImvivaBiotechPR@icrhealthcare.com
(646) 667-1861
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