NCT05397184: TvT CAR7

Base Edited CAR7 T Cells to Treat T Cell Malignancies (TvT CAR7)

Status unknown Phase 1 Last updated 5 July 2023

What this trial tests

Phase 1 trial testing Cryopreserved BE CAR7 T cells (BE752TBCCLCAR7PBL) in Relapsed/Refractory T-cell Acute Lymphoid Leukaemia in 10 participants. Status unknown.

Timeline

19 April 2022

Primary endpoint
1 April 2024

28 February 2025

Quick facts

Lead sponsor	Great Ormond Street Hospital for Children NHS Foundation Trust
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	19 April 2022
Primary completion	1 April 2024
Estimated completion	28 February 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• Cryopreserved BE CAR7 T cells (BE752TBCCLCAR7PBL) — full drug profile →

Conditions studied

• Relapsed/Refractory T-cell Acute Lymphoid Leukaemia — all drugs for Relapsed/Refractory T-cell Acute Lymphoid Leukaemia →

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Who can join

Adults 6 Months to 16, any sex, with Relapsed/Refractory T-cell Acute Lymphoid Leukaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

T-cell leukaemia is an uncommon type of blood cell cancer that affects white blood cells (T cells). This phase I clinical trial will treat children aged 6 months up to 16 years with T cell leukaemia which has come back (relapsed) after chemotherapy or is not responding to chemotherapy (refractory). The cell therapy is made from white blood cells (T cells) collected from a healthy donor and changed so they can kill other T cells, including leukaemia cells. These 'ready-made' CAR T cells have been made using a new technique called CRISPR base editing to modify them DNA code and have been given the name BE CAR-7. This technique allows them to work after chemotherapy and also disarms them to prevent effects against normal cells. The main aim of this study is to assess the safety of the BE CAR-7 treatment and to see if ready-made CAR T cells can eradicate T cell leukaemia ahead of a planned bone marrow transplant.

Publications & conference data

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

1. Viral vectors and extracellular vesicles: innate delivery systems utilized in CRISPR/Cas-mediated cancer therapy.
   Ahmadi SE, Soleymani M, Shahriyary F, Amirzargar MR, et al · · 2023 · cited 55× · PMID 36854897 · DOI 10.1038/s41417-023-00597-z
2. CRISPR/Cas9 Landscape: Current State and Future Perspectives.
   Tyumentseva M, Tyumentsev A, Akimkin V. · · 2023 · cited 44× · PMID 38003266 · DOI 10.3390/ijms242216077
3. In the business of base editors: Evolution from bench to bedside.
   Porto EM, Komor AC. · · 2023 · cited 39× · PMID 37043430 · DOI 10.1371/journal.pbio.3002071
4. From bench to bedside: cutting-edge applications of base editing and prime editing in precision medicine.
   Xu W, Zhang S, Qin H, Yao K. · · 2024 · cited 38× · PMID 39707395 · DOI 10.1186/s12967-024-05957-3
5. Current trends of clinical trials involving CRISPR/Cas systems.
   Zhang S, Wang Y, Mao D, Wang Y, et al · · 2023 · cited 35× · PMID 38020120 · DOI 10.3389/fmed.2023.1292452
6. In vivo delivery of CRISPR-Cas9 genome editing components for therapeutic applications.
   Huang K, Zapata D, Tang Y, Teng Y, et al · · 2022 · cited 32× · PMID 36334354 · DOI 10.1016/j.biomaterials.2022.121876
7. State of the art CRISPR-based strategies for cancer diagnostics and treatment.
   Di Carlo E, Sorrentino C. · · 2024 · cited 29× · PMID 39696697 · DOI 10.1186/s40364-024-00701-x
8. Precise genome-editing in human diseases: mechanisms, strategies and applications.
   Zheng Y, Li Y, Zhou K, Li T, et al · · 2024 · cited 28× · PMID 38409199 · DOI 10.1038/s41392-024-01750-2