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

NCT ID: NCT07131085

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-12-31

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.

Conditions

MDS; AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with R/R AML or MDS

Patients with R/R AML or MDS. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH101 product.

Group Type: EXPERIMENTAL

Allogeneic TCR-enhanced γδ T cell(QH101)

Intervention Type: DRUG

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)

Fludarabine (FLU)

Intervention Type: DRUG

Intravenous fludarabine 20\~30 mg/m\^2/day on days -5, -4, and -3

Cyclophosphamide (CTX)

Intervention Type: DRUG

Intravenous cyclophosphamide 300\~500 mg/m\^2/day on days -5, -4, and -3.

Interventions

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)

Intervention Type: DRUG

Fludarabine (FLU)

Intravenous fludarabine 20\~30 mg/m\^2/day on days -5, -4, and -3

Intervention Type: DRUG

Cyclophosphamide (CTX)

Intravenous cyclophosphamide 300\~500 mg/m\^2/day on days -5, -4, and -3.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Patients with a history of severe central nervous system disorders, such as uncontrolled epileptic seizures, stroke, severe brain injury with aphasia, paralysis, dementia, Parkinson's disease, or mental disorders;

2. New York Heart Association (NYHA) Class III or IV heart failure;

3. Undergone coronary angioplasty, coronary stent implantation, or coronary artery bypass surgery; or experienced thrombotic or embolic events (e.g., cerebrovascular events [including transient ischemic attacks, but excluding lacunar cerebral infarction], deep vein thrombosis [excluding deep vein thrombosis caused by PICC catheter placement], pulmonary embolism, etc.);

4. Presence of disseminated intravascular coagulation;

5. Presence of severe autoimmune diseases or immunodeficiency disorders;

6. Presence of active graft-versus-host disease requiring ongoing systemic treatment;

7. Subjects currently receiving systemic steroid or other immunosuppressive therapy prior to screening, and who are determined by the investigator to require long-term use of such therapy after enrollment (excluding inhaled or topical use);

8. Other severe medical conditions deemed inappropriate for enrollment by the investigator (e.g., uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.);

9. Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV-positive, or positive syphilis test results;

10. Other severe or persistent active infections;

11. Adverse events related to systemic immunotherapy (including other investigational drugs or medical device interventions) prior to screening have not yet decreased to Grade 1 severity or returned to baseline status;

12. Discontinuation of immunosuppressive agents for less than 2 weeks;

13. History of allergy to any component of the cellular product;

14. Vaccination or any surgical procedure within 4 weeks prior to screening;

15. Other conditions deemed by the investigator to potentially increase the risk to the subject or interfere with trial results.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Zhu

Director of Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiaoyu Zhu

Role: CONTACT

xiaoyuz@ustc.edu.cn

15255456091

Guangyu Sun

Role: CONTACT

sunguangyu_vip@foxmail.com

13956970687

Other Identifiers

QH10104-RML-01（0）

Identifier Type: -

Identifier Source: org_study_id