MDSPhase 1NCT07131085
QH101 Cell Therapy Relapsed/Refractory(R/R) Acute Myeloid Leukemia(AML) and Myelodysplastic Syndromes(MDS)
A Phase 1 study testing Allogeneic TCR-enhanced γδ T cell(QH101), Fludarabine (FLU) and Cyclophosphamide (CTX) in people with MDS and AML, run by Anhui Provincial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- What is being tested?
- Allogeneic TCR-enhanced γδ T cell(QH101), Fludarabine (FLU) and Cyclophosphamide (CTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
- New York Heart Association (NYHA) Class III or IV heart failure;
- 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.);
- Presence of disseminated intravascular coagulation;
- Presence of severe autoimmune diseases or immunodeficiency disorders;
- Presence of active graft-versus-host disease requiring ongoing systemic treatment;
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- 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);
- Other severe medical conditions deemed inappropriate for enrollment by the investigator (e.g., uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.);
- Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV-positive, or positive syphilis test results;
- Other severe or persistent active infections;
- 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;
- Discontinuation of immunosuppressive agents for less than 2 weeks;
- History of allergy to any component of the cellular product;
- Vaccination or any surgical procedure within 4 weeks prior to screening;
- Other conditions deemed by the investigator to potentially increase the risk to the subject or interfere with trial results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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.
- Being tested
- Allogeneic TCR-enhanced γδ T cell(QH101), Fludarabine (FLU), Cyclophosphamide (CTX)
- Keywords
- TCR, BTN, γδT, allogeneic, cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic TCR-enhanced γδ T cell(QH101)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)Drug
Intravenous fludarabine 20~30 mg/m^2/day on days -5, -4, and -3
Cyclophosphamide (CTX)Drug
Intravenous cyclophosphamide 300~500 mg/m^2/day on days -5, -4, and -3.
| Study group | Role | What they receive |
|---|---|---|
| Patients with R/R AML or MDS | Experimental | Patients with R/R AML or MDS. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH101 product. Receives: Drug: Allogeneic TCR-enhanced γδ T cell(QH101); Drug: Fludarabine (FLU); Drug: Cyclophosphamide (CTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE
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.
Measured: 12 months
Incidence of dose-limiting toxicity (DLT)
Measured: Within 28 days post-cell infusion
Secondary outcomes (4)
Pharmacokinetics: Persistence of QH101
Persistence of QH101 assessed by number in peripheral blood.
Measured: 12 months
Overall response rate (ORR)
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)
Measured: 12 months
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)
Measured: 12 months
Pharmacodynamics: Peak level of cytokines in serum
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.
Measured: Up to 28 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Zhu, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131085
- Sponsor's protocol ID
- QH10104-RML-01（0）
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07131085
- Acronym / sponsor ID
- QH10104-RML-01（0）
- Keywords
- TCR, BTN, γδT, allogeneic, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with R/R AML or MDS | Experimental | Drug: Allogeneic TCR-enhanced γδ T cell(QH101), Drug: Fludarabine (FLU), Drug: 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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;
- New York Heart Association (NYHA) Class III or IV heart failure;
- 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.);
- Presence of disseminated intravascular coagulation;
- Presence of severe autoimmune diseases or immunodeficiency disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patients with R/R AML or MDS |
| Fludarabine (FLU)Intravenous fludarabine 20~30 mg/m^2/day on days -5, -4, and -3 | Drug | Patients with R/R AML or MDS |
| Cyclophosphamide (CTX)Intravenous cyclophosphamide 300~500 mg/m^2/day on days -5, -4, and -3. | Drug | Patients with R/R AML or MDS |
Primary outcome
Incidence of AE
Time frame: 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)
Time frame: Within 28 days post-cell infusion
4 secondary outcomes
Pharmacokinetics: Persistence of QH101
Time frame: 12 months
Overall response rate (ORR)
Time frame: 12 months
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)
Time frame: 12 months
Pharmacodynamics: Peak level of cytokines in serum
Time frame: Up to 28 days after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic TCR-enhanced γδ T cell(QH101), Fludarabine (FLU) and Cyclophosphamide (CTX) in people with MDS and AML, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.