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December 8, 2025BloodOpen Access

A single-arm, open-label, multi-center, phase 1b/2 Study to evaluate the safety, efficacy, and cellular pharmacokinetic profile of CTD402 in participants with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL) (TENACITY-01)

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Authors

LMLori MufflyStanford Health CareRCRyan D. CassadayCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South AfricaGRGregory W. RoloffUniversity of Chicago

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Implication

Single-arm trial finds safety and efficacy of CTD402 in lymphoblastic lymphoma, suggesting potential for allogeneic stem cell transplantation.

Key Points

  • This study aims to evaluate CTD402 therapy's safety and efficacy in patients with relapsed/refractory T-ALL/LBL.
  • Single-arm, open-label, multi-center Phase 1b/2 study
  • 18 participants in Phase 1b to assess safety
  • 36 participants in Phase 2 to validate efficacy
  • Participants receive 400 x 10^6 CTD402 CAR-T cells after lymphodepletion with fludarabine and cyclophosphamide
  • Disease assessments include bone marrow aspirate and imaging as needed.
  • Observed safety profile with definition of dose limiting toxicities
  • Initial evidence of anti-leukemic activity with high MRD negative remission rates
  • Durable remissions noted, especially in patients proceeding to HSCT.
  • Assessment of adverse events is ongoing.

Cite This Study

Muffly et al. (2025) studied this question.

synapsesocial.com/papers/69362f5a4fa91c937236db28https://doi.org/10.1182/blood-2025-5954
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1CTD402, allogeneic anti-CD7 CAR t-cell, in relapsed or refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) - report of clinical outcomes at the recommended phase 2 dose (RP2D)2025 · 1 citations
  2. 2Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study.2024 · 3 citations
  3. 3A Phase I, open-label study of CTD402, a universal CD7-targeting CAR T-cell therapy, in patients with relapsed/refractory severe aplastic anemia2025
  4. 4Sequential CD19 and CD22 CART for relapsed and refractory B cell ALL: Phase I results2025
  5. 5Anti-CD7 CAR T-cell therapy for ultra-high-risk relapsed/refractory T-ALL/lbl: Insights into lineage switch and consolidation strategies2025