NCT07131085

QH101 Cell Therapy Relapsed/Refractory(R/R) Acute Myeloid Leukemia(AML) and Myelodysplastic Syndromes(MDS)

Clinical Study on the Safety and Efficacy of QH101 in Patients With Relapsed/Refractory Acute Myeloid Leukemia(R/R AML) and Relapsed/Refractory Myelodysplastic Syndromes(R/R MDS)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence. Patients with R/R AML face particularly poor prognoses, with conventional chemotherapy and targeted therapies achieving suboptimal complete remission rates and long-term survival below 10%. Similarly, R/R MDS patients typically demonstrate median overall survival of less than one year (with TP53-mutated cases showing even poorer outcomes of 3-6 months), making clinical trial participation the most viable therapeutic option. The development of effective treatments for R/R AML/MDS presents significant challenges due to:1)The paucity of disease-specific molecular targets;2)The slow progress in drug development. Allogeneic γδ T-cell therapy featuring enhanced TCR functionality and multi-mechanism tumoricidal activity represents a promising investigational approach for addressing R/R AMLMDS. This innovative strategy combines the advantages of: 1)Improved target recognition through TCR enhancement; 2)Multi-faceted tumor-killing mechanisms; 3)Potential for better safety and persistence profiles.

Conditions

• MDS
• AML

Interventions

Type	Name	Description
DRUG	Allogeneic TCR-enhanced γδ T cell(QH101)	dose escalation (3+3) : dose 1 (5×10\^8 enTCR γδ cells) , dose 2 (1.5×10\^9 enTCR γδ cells), dose 3 (3×10\^9 enTCR γδ cells)
DRUG	Fludarabine (FLU)	Intravenous fludarabine 20\~30 mg/m\^2/day on days -5, -4, and -3
DRUG	Cyclophosphamide (CTX)	Intravenous cyclophosphamide 300\~500 mg/m\^2/day on days -5, -4, and -3.

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-08-20
• Last updated: 2025-08-20