NCT03953599

CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients

Completed Phase 1 Last updated 1 February 2022

What this trial tests

Phase 1 trial testing CD19-STAR-T cells in B Cell Malignancy in 18 participants. Completed in 31 December 2021.

Timeline

1 July 2019

Primary endpoint
1 July 2021

31 December 2021

Quick facts

Lead sponsor	Hebei Yanda Ludaopei Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 July 2019
Primary completion	1 July 2021
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• CD19-STAR-T cells — full drug profile →

Conditions studied

• B Cell Malignancy — all drugs for B Cell Malignancy →

Sponsor

Hebei Yanda Ludaopei Hospital

Who can join

Adults 1 to 70, any sex, with B Cell Malignancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).

Publications & conference data

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

1. A novel adoptive synthetic TCR and antigen receptor (STAR) T-Cell therapy for B-Cell acute lymphoblastic leukemia.
   Wang J, Zhang X, Zhou Z, Liu Y, et al · · 2022 · cited 31× · PMID 35491511 · DOI 10.1002/ajh.26586
2. Analysis benefits of a second Allo-HSCT after CAR-T cell therapy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia who relapsed after transplant.
   Cao XY, Zhang JP, Zhao YL, Xiong M, et al · · 2023 · cited 11× · PMID 37469510 · DOI 10.3389/fimmu.2023.1191382
3. Targeting cancer with precision: strategical insights into TCR-engineered T cell therapies.
   Lin P, Lin Y, Mai Z, Zheng Y, et al · · 2025 · cited 9× · PMID 39744228 · DOI 10.7150/thno.104594
4. Transitioning from native to synthetic receptors: broadening T-cell engineering and beyond.
   Yu L, Liu Y, Lin X. · · 2025 · cited 5× · PMID 40481182 · DOI 10.1038/s41423-025-01304-8
5. Converting TCR-based chimeric antigen receptor STAR into dual-specific targeting receptor for cancer immunotherapy.
   Yu L, Zhou Z, Yu H, Liu Y, et al · · 2025 · cited 4× · PMID 39916328 · DOI 10.1016/j.ymthe.2025.02.001
6. Concept CARs are picking up speed.
   Mansilla-Soto J, Milone MC. · · 2025 · cited 1× · PMID 40340247 · DOI 10.1016/j.ymthe.2025.05.008
7. The TCR and LCK: foundations for T-cell activation and therapeutic innovation.
   Woessner NM, Uleri V, Stepanek O, Minguet S. · · 2025 · PMID 41601693 · DOI 10.3389/fimmu.2025.1737013
8. CAR-T cell exhaustion in B cell lymphoma: Current status, mechanisms, and potential solutions.
   Zhao R, Xia J, Zheng Y, Huang W, et al · · 2026 · PMID 41502492 · DOI 10.1016/j.omton.2025.201099