NCT03896854

CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status unknown Phase 1, PHASE2 Last updated 29 November 2023

What this trial tests

Phase 1, PHASE2 trial testing CART-19 in Acute Myeloid Leukemia in 15 participants. Status unknown.

Timeline

18 October 2017

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	18 October 2017
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• CART-19

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd — full company profile →

Who can join

Adults 6 to 65, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Publications & conference data

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

1. T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments.
   Daver N, Alotaibi AS, Bücklein V, Subklewe M. · · 2021 · cited 178× · PMID 33953290 · DOI 10.1038/s41375-021-01253-x
2. CAR-T cell therapy for cancer: current challenges and future directions.
   Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
3. Recent Advances in Immune-Based Therapies for Acute Myeloid Leukemia.
   Restelli C, Ruella M, Paruzzo L, Tarella C, et al · · 2024 · cited 36× · PMID 38904305 · DOI 10.1158/2643-3230.bcd-23-0202
4. Outcomes with chimeric antigen receptor t-cell therapy in relapsed or refractory acute myeloid leukemia: a systematic review and meta-analysis.
   Shahzad M, Nguyen A, Hussain A, Ammad-Ud-Din M, et al · · 2023 · cited 28× · PMID 37168849 · DOI 10.3389/fimmu.2023.1152457
5. Targets for chimeric antigen receptor T-cell therapy of acute myeloid leukemia.
   Schorr C, Perna F. · · 2022 · cited 21× · PMID 36605213 · DOI 10.3389/fimmu.2022.1085978
6. Small-Molecule Compounds Boost CAR-T Cell Therapy in Hematological Malignancies.
   Cao X, Jin X, Zhang X, Utsav P, et al · · 2023 · cited 20× · PMID 36701037 · DOI 10.1007/s11864-023-01049-4
7. Harnessing T Cells to Target Pediatric Acute Myeloid Leukemia: CARs, BiTEs, and Beyond.
   Epperly R, Gottschalk S, Velasquez MP. · · 2020 · cited 19× · PMID 32079207 · DOI 10.3390/children7020014
8. Antigen-Specific TCR-T Cells for Acute Myeloid Leukemia: State of the Art and Challenges.
   Kang S, Li Y, Qiao J, Meng X, et al · · 2022 · cited 17× · PMID 35356211 · DOI 10.3389/fonc.2022.787108