NCT04984356

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

Completed Phase 1 Last updated 30 September 2025

What this trial tests

Phase 1 trial testing WU-CART-007 in T-cell Acute Lymphoblastic Leukemia in 28 participants. Completed in 8 August 2024.

Timeline

14 January 2022

Primary endpoint
8 August 2024

8 August 2024

Quick facts

Lead sponsor	Wugen, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	14 January 2022
Primary completion	8 August 2024
Estimated completion	8 August 2024
Sites	12 locations across France, Netherlands, United States, Australia

Drugs / interventions tested

• WU-CART-007 — full drug profile →

Conditions studied

• T-cell Acute Lymphoblastic Leukemia — all drugs for T-cell Acute Lymphoblastic Leukemia →
• Lymphoblastic Lymphoma — all drugs for Lymphoblastic Lymphoma →

Sponsor

Wugen, Inc. — full company profile →

Who can join

12 and older, any sex, with T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. mRNA-based vaccines and therapeutics: an in-depth survey of current and upcoming clinical applications.
   Wang YS, Kumari M, Chen GH, Hong MH, et al · · 2023 · cited 93× · PMID 37805495 · DOI 10.1186/s12929-023-00977-5
2. Leveraging CRISPR gene editing technology to optimize the efficacy, safety and accessibility of CAR T-cell therapy.
   Lei T, Wang Y, Zhang Y, Yang Y, et al · · 2024 · cited 68× · PMID 39455854 · DOI 10.1038/s41375-024-02444-y
3. Allogeneic CAR-T Therapy Technologies: Has the Promise Been Met?
   Lonez C, Breman E. · · 2024 · cited 57× · PMID 38247837 · DOI 10.3390/cells13020146
4. Recent updates on allogeneic CAR-T cells in hematological malignancies.
   Mansoori S, Noei A, Maali A, Seyed-Motahari SS, et al · · 2024 · cited 34× · PMID 39227937 · DOI 10.1186/s12935-024-03479-y
5. An "off-the-shelf" CD2 universal CAR-T therapy for T-cell malignancies.
   Xiang J, Devenport JM, Carter AJ, Staser KW, et al · · 2023 · cited 29× · PMID 37798328 · DOI 10.1038/s41375-023-02039-z
6. Navigating the intricate in-vivo journey of lipid nanoparticles tailored for the targeted delivery of RNA therapeutics: a quality-by-design approach.
   Haghighi E, Abolmaali SS, Dehshahri A, Mousavi Shaegh SA, et al · · 2024 · cited 28× · PMID 39543630 · DOI 10.1186/s12951-024-02972-w
7. Current advances of CRISPR-Cas technology in cell therapy.
   Qiu HY, Ji RJ, Zhang Y. · · 2022 · cited 25× · PMID 37193354 · DOI 10.1016/j.cellin.2022.100067
8. Advances and prospects of RNA delivery nanoplatforms for cancer therapy.
   Attia MS, Kijanka G, Nguyen NT, Zhang J, et al · · 2025 · cited 24× · PMID 40041887 · DOI 10.1016/j.apsb.2024.09.009