Drugs / CTD402
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07070219 | Oct 2025 → Sep 2028 expected | acute lymphoblastic leukemia, lymphoblastic lymphoma | Imviva Bio | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Imviva Bio | Results ImvivaBio Presents Studies on CTD402 Allogeneic CAR-T Therapy at EHA2026 Congress imvivabio.com ↗
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. |
| 2026-05-29 | Imviva Bio | Results ImvivaBio to Present Data from Clinical Studies of CTA313 and CTD402 Validating its ANSWER™ Allogeneic CAR-T Platform in Pediatric and Adult Patient Populations at EULAR and EHA 2026 Congresses imvivabio.com ↗
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 |
| 2026-01-27 | Imviva Bio | Regulatory ImvivaBio Receives FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma imvivabio.com ↗
ImvivaBio, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to CTD402, the company’s investigational allogeneic anti-CD7 CAR-T cell therapy for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). |
| 2025-12-08 | Imviva Bio | Results Validating Data for CAR-T Cell Therapies CTD402 and CTA311 in Five Presentations at the 67th American Society of Hematology Annual Meeting imvivabio.com ↗
The first poster ( Abstract #5954 ) highlighted the promising ‘off-the-shelf' CAR-T approach of CTD402, being evaluated in the Phase 1b/2 TENACITY-01 clinical trial ( NCT07070219 ) for the treatment of R/R T-ALL and LBL. |
| 2025-12-08 | Imviva Bio | Results ImvivaBio Presents Validating Data for CAR-T Cell Therapies CTD402 and CTA311 in Five Presentations at the 67th American Society of Hematology Annual Meeting imvivabio.com ↗
Preliminary data from earlier studies suggest CTD402 achieves high MRD-negative remission rates and durable responses, supporting its potential as a transformative therapy for R/R T-ALL/LBL. |
| 2025-12-08 | Imviva Bio | Results ImvivaBio Presents Clinical Breakthroughs for CTD402 in High-Mortality T-Cell and Myeloid Leukemias at the 67th American Society of Hematology Annual Meeting imvivabio.com ↗
ImvivaBio, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today presented clinical data for CTD402, its investigational allogeneic anti-CD7 CAR-T cell therapy, in two oral sessions at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. |
| 2025-12-08 | Imviva Bio | Results Clinical Breakthroughs for CTD402 in High-Mortality T-Cell and Myeloid Leukemias presented at the 67th American Society of Hematology Annual Meeting imvivabio.com ↗
Safety was consistent with T-ALL/LBL observations, with manageable cytokine release syndrome and no dose-limiting toxicities or treatment-related deaths, and cytopenia resolved in most responders. |
| 2025-10-28 | Imviva Bio | Regulatory Imviva Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for CTD402 in Relapsed/Refractory T-ALL/LBL imvivabio.com ↗
We are pleased to receive RMAT designation for CTD402. |
| 2025-06-25 | Imviva Bio | Results Latest Clinical Data on Universal CAR-T Therapy CTD402 for Patients with R/R T-ALL/LBL presented at EHA 2025 imvivabio.com ↗
At this event, Bioheng Therapeutics presented the latest clinical data on its universal CAR-T product, CTD402, for the treatment of patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), in the form of an oral report. |
| 2025-02-28 | Imviva Bio | Regulatory FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL imvivabio.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CTD402 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07070219 ↗ |