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

Not Applicable

Not yet recruiting

• Conditions: MDS; AML
• Interventions: Drug: Allogeneic TCR-enhanced γδ T cell(QH101); Drug: Fludarabine (FLU); Drug: Cyclophosphamide (CTX)

• Registration Number: NCT07131085
• Lead Sponsor: Anhui Provincial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study Start: 2025-08-15
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with R/R AML or MDS	Allogeneic TCR-enhanced γδ T cell(QH101)	Patients with R/R AML or MDS. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH101 product.
Patients with R/R AML or MDS	Fludarabine (FLU)	Patients with R/R AML or MDS. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH101 product.
Patients with R/R AML or MDS	Cyclophosphamide (CTX)	Patients with R/R AML or MDS. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH101 product.

Primary Outcome Measures

Name	Time	Method
Incidence of AE	12 months	AE is defined as any adverse medical event occurring from the date of lymphocyte depletion to 12 months after QH101 infusion. Among these, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) are graded according to the standards set by the American Society for Transplantation and Cellular Therapy (ASTCT). Graft-versus-host disease (GVHD) is graded according to the standards defined by the Mount Sinai Acute GVHD International Consortium. Other AEs are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of dose-limiting toxicity (DLT)	Within 28 days post-cell infusion

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Persistence of QH101	12 months	Persistence of QH101 assessed by number in peripheral blood.
Overall response rate (ORR)	12 months	The proportion of subjects achieving CR (complete remission)/CRh (complete remission with partial hematological recovery)/CRi (complete remission with incomplete hematological recovery)/PR (partial remission)
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)	12 months
Pharmacodynamics: Peak level of cytokines in serum	Up to 28 days after infusion	The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), interferon-γ(IFN-γ). Peak was defined as the maximum post-baseline level of the cytokine.