NCT03114670

Donor-derived Anti-CD123-CART Cells for Recurred AML After Allo-HSCT

Status unknown Phase 1 Last updated 14 June 2017

What this trial tests

Phase 1 trial testing CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells in Adult Acute Myeloid Leukemia in 20 participants. Status unknown.

Timeline

25 March 2017

Primary endpoint
18 March 2019

18 March 2021

Quick facts

Lead sponsor	Affiliated Hospital to Academy of Military Medical Sciences
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	25 March 2017
Primary completion	18 March 2019
Estimated completion	18 March 2021
Sites	1 location across China

Drugs / interventions tested

• CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells — full drug profile →

Conditions studied

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Who can join

18 and older, any sex, with Adult Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the treatment of AML. The investigators start the Phase I study aimed to treat recurred post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.

Publications & conference data

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

1. Cancer Stem Cells-Origins and Biomarkers: Perspectives for Targeted Personalized Therapies.
   Walcher L, Kistenmacher AK, Suo H, Kitte R, et al · · 2020 · cited 688× · PMID 32849491 · DOI 10.3389/fimmu.2020.01280
2. Treatment of Relapsed Acute Myeloid Leukemia.
   Thol F, Ganser A. · · 2020 · cited 209× · PMID 32601974 · DOI 10.1007/s11864-020-00765-5
3. Next generation chimeric antigen receptor T cells: safety strategies to overcome toxicity.
   Yu S, Yi M, Qin S, Wu K. · · 2019 · cited 208× · PMID 31429760 · DOI 10.1186/s12943-019-1057-4
4. 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
5. Autologous CD33-CAR-T cells for treatment of relapsed/refractory acute myelogenous leukemia.
   Tambaro FP, Singh H, Jones E, Rytting M, et al · · 2021 · cited 159× · PMID 33833386 · DOI 10.1038/s41375-021-01232-2
6. CD123 as a Therapeutic Target in the Treatment of Hematological Malignancies.
   Testa U, Pelosi E, Castelli G. · · 2019 · cited 114× · PMID 31547472 · DOI 10.3390/cancers11091358
7. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
8. Next generations of CAR-T cells - new therapeutic opportunities in hematology?
   Tomasik J, Jasiński M, Basak GW. · · 2022 · cited 98× · PMID 36389658 · DOI 10.3389/fimmu.2022.1034707