Drugs / WU-CART-007
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT05377827 | Oct 2023 → Jun 2026 overdue | Sezary syndrome, T-cell prolymphocytic leukemia, acute myeloid leukemia, adult T-cell leukemia/lymphoma +9 | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04984356 | Jan 2022 → Aug 2024 | T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma | Wugen, Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06514794 | Jan 2025 → Dec 2026 expected | T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma | Wugen, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-04-02 | Wugen, Inc. | Regulatory Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel wugen.com ↗
Wugen was invited by the FDA to participate in the CDRP program, which selects up to nine development programs annually across the FDA’s two product review centers for biologics and drugs. |
| 2026-01-21 | Wugen, Inc. | Regulatory U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma wugen.com ↗
Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational CAR-T cell therapy, Sofi-cel. |
| 2025-12-05 | Wugen, Inc. | Results Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting wugen.com ↗
In the Phase 1/2 Study, Sofi-cel exhibited over one-hundred-fold expansion following infusion and persisted in circulation for up to three months. |
| 2024-12-05 | Wugen, Inc. | Results Wugen to Present Clinical Data at the 2024 ASH Annual Meeting Ahead of Pivotal Trial Launch of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007 wugen.com ↗
Results from Phase 1/2 showed continued anti-leukemic activity and clinically manageable safety in adults and adolescents. |
| 2024-05-20 | Wugen, Inc. | Regulatory Wugen Announces RMAT and PRIME Designations for WU-CART-007 to Accelerate Regulatory Reviews and Plans to Present Positive Phase 2 Study Findings at European Hematology Association (EHA) 2024 in June wugen.com ↗
Specifically, Wugen received Regenerative Medicine Advanced Therapy (RMAT) designation in the United States and PRIME (“Priority Medicines”) designation in the European Union for WU-CART-007 for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). |
| 2023-12-11 | Wugen, Inc. | Results Wugen Presents Latest Data from First-In-Human Phase 1/2 Trial of WU-CART-007 in Patients with Difficult-to-Treat Blood Cancers at American Society of Hematology Annual Meeting wugen.com ↗
As of Nov. 28, 2023, 25 patients have been dosed with WU-CART-007. |
| 2023-06-09 | Wugen, Inc. | Results Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress wugen.com ↗
The Objective Response Rate (ORR) in efficacy evaluable patients was 57% overall (4/7), including 2 Complete Responses (CR), 1 morphological leukemia-free state (MLFS), and 1 Partial Response (PR). |
| 2023-05-11 | Wugen, Inc. | Results Wugen Announces Multiple Presentations at the European Hematology Association (EHA) 2023 Congress wugen.com ↗
The poster presentation includes new clinical data highlighting the promising safety profile of WU-CART-007 and preliminary evidence of anti-leukemic activity in patients with R/R T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). |
| 2022-07-20 | Alpha Biopharma (Jiangsu) Co., Ltd. | Regulatory Wugen自主研发的WU-CART-007已被美国 FDA授予快速通道和罕见儿科疾病认定，用于治疗 R/R T-ALL/LBL alphabiopharma.com ↗
WU-CART-007已获得美国食品药品监督管理局（FDA）快速通道和罕见儿科疾病认定（RPDD）。 |
| 2022-07-19 | Wugen, Inc. | Regulatory Wugen Receives U.S. FDA Fast Track and Rare Pediatric Disease Designations for WU-CART-007 for the Treatment of R/R T-ALL/LBL wugen.com ↗ |
| 2021-12-13 | Wugen, Inc. | Results Wugen Presents New Preclinical Data Supporting the Safety and Efficacy of WU-CART-007 for T-Cell Malignancies at the 63rd Annual Society of Hematology (ASH) Annual Meeting wugen.com ↗ |
| 2021-11-05 | Wugen, Inc. | Results Wugen Announces Data Presentation at the 63rd Annual Society of Hematology (ASH) Annual Meeting wugen.com ↗
The results demonstrate preclinical safety and anti-tumor activity of WU-CART-007. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | WU-CART-007 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05377827 ↗ |
| Modality | Cell therapy | “A CD7-directed chimeric antigen receptor (CAR) T-cell product.” NCT04984356 ↗ |
| Route | Intravenous | “A single IV infusion of WU-CART-007 Cells on Day 1” NCT04984356 ↗ |
| Target | CD7 | “WU-CART-007 is a CD7-targeting” PMID 40445850 ↗ Sep 2025 |