LeukemiaPhase 1NCT07120607
Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia
A Phase 1 study testing CD7 CAR-γδT cell（QH106）, Fludarabine (FLU) and Cyclophosphamide (CTX) in people with Leukemia, run by Anhui Provincial Hospital.
Trial summary
CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0/M1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- CD7 CAR-γδT cell（QH106）, 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
- 18 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
- Age ≥ 14 years, no gender restrictions;
- Diagnosed with TALL/LBL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2023.V2); or diagnosed with AML according to the NCCN Acute Myeloid Leukemia Clinical Practice Guidelines (2023.V6);
- Meet the criteria for relapsed or refractory T-ALL/LBL, including any of the following:
- Relapsed: after achieving complete remission(CR), peripheral blood or bone marrow shows >5% blast cells or extramedullary lesions in any site;
- Refractory: primary refractory cases that did not achieve CR after standard induction chemotherapy.
- Or meets the criteria for relapsed or refractory AML, including any of the following:
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- Relapsed: leukemic cells reappear in peripheral blood or ≥5% of blast cells in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemic cell infiltration after achieving CR;
- Refractory: primary cases that remain unresponsive after two cycles of standard treatment; Patients who relapse within 12 months after consolidation therapy following CR; patients who relapse after 12 months and are unresponsive to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;
- Cytological confirmation of tumor cell immunophenotyping as CD7-positive during screening;
- Expected survival time exceeding 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Organ function meets the following requirements:
- Liver function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total bilirubin ≤ 3.0 × ULN.
- Renal function must meet the following criteria: serum creatinine ≤ 1.5 × upper limit of normal (ULN);
- Cardiac function: echocardiogram showing left ventricular ejection fraction ≥ 50%;
- Pulmonary function: normal oxygen saturation without oxygen supplementation.
- Female participants of childbearing potential and male participants whose partners are of childbearing potential must use medically approved contraceptive measures or abstain from sexual intercourse during the study treatment period and for at least 6 months after the study treatment period. Female participants of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
- No significant genetic disorders;
- The subject or their legal guardian voluntarily participates in this study, understands the trial information, objectives, and risks described in the informed consent form, and can provide a signed and dated informed consent form;
- The subject or their legal guardian is willing and able to comply with all trial requirements.
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;
- Heart failure classified as NYHA functional class III or IV;
- Any of the following unstable cardiovascular conditions occurring within the past 6 months prior to screening (including but not limited to): unstable angina, cerebral ischemia or cerebrovascular accident, myocardial infarction, severe arrhythmias requiring medication (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes); Undergone coronary angioplasty, coronary artery stent implantation, or coronary artery bypass surgery; experienced thrombosis or embolism 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, as determined by the investigator, will 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 status, 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;
- Immunosuppressive agents have been discontinued for less than 2 weeks;
- Those who have received CAR-T cell therapy in the past;
- History of allergy to any component of the cell 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 CD7 CAR-γδT Cell Injection for the Treatment of Relapsed/Refractory Leukemia
CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0/M1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk genetic abnormalities (such as TP53 mutations or complex karyotypes). CD7-positive AML patients typically have poor prognosis, poor response to standard chemotherapy, and shorter overall survival (OS). Targeted CD7 cell therapies may represent a promising direction for the treatment of these diseases.
Read the detailed description
This study is a single-arm,open-label, dose-escalation clinical trial. It is planned to enroll 9-18 patients with CD7-positive relapsed/refractory T-ALL/LBL and relapsed/refractory AML. The study will use a 3+3 design for dose escalation, with three initial dose groups: 1*10^8 CAR+ cells, 3*10^8 CAR+ cells, and 6*10^8 CAR+ cells.
- Conditions
- Leukemia
- Being tested
- CD7 CAR-γδT cell（QH106）, Fludarabine (FLU), Cyclophosphamide (CTX)
- Keywords
- CAR γδ T cells, CD7 positive, Recurrent refractory
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD7 CAR-γδT cell（QH106）Biological
Allogenic CD7 CAR-γδT cell，Intravenous on day0; dose escalation (3+3) : dose 1 (1 × 10^8 CAR+ cells) , dose 2 (3 × 10^8CAR+ cells/kg，dose 3 (6× 10^8 CAR+ cells）;
Fludarabine (FLU)Drug
Intravenous fludarabine 30~50 mg/m^2/day on days-5, -4, and -3；
Cyclophosphamide (CTX)Drug
Intravenous cyclophosphamide 500~1000 mg/m^2/day on days -5, -4, and -3.
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia | Experimental | Not described Receives: Biological: CD7 CAR-γδT cell（QH106）; 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 Adverse Events (AEs)
AE is defined as any adverse medical event from the date of lymphocyte depletion chemotherapy to 12 months after QH106 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versus-host disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Measured: 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: First infusion date of QH106 up to 28 days
Secondary outcomes (8)
Pharmacodynamics: Peak level of cytokines in serum
Measured: Up to 28 days after infusion
Pharmacokinetics: Persistence of QH106
Persistence of QH106 assessed by number in peripheral blood
Measured: 12 months
Overall Response rate (ORR)
CR (complete remission) /CRh (CR with partial hematological recovery) The proportion of subjects who achieved remission /CRi (complete remission with incomplete hematological recovery) /PR (partial remission)
Measured: 12 months
Negative remission rate of minimal residual disease (MRD) in leukemia
Measured: 12 month
Duration of remission (DOR)
Measured: 12 month
Leukemia-free survival period(LFS)
Measured: 12 month
Overall survival (OS)
Measured: 12 month
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (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 LeukemiaStudies of the same condition, open and under way.
- 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
- NCT07120607
- Sponsor's protocol ID
- QH10601-TAL-01（0）
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 13 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 13 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 CD7 CAR-γδT Cell Injection for the Treatment of Relapsed/Refractory Leukemia
- ClinicalTrials.gov ID
- NCT07120607
- Acronym / sponsor ID
- QH10601-TAL-01（0）
- Conditions
- Leukemia
- Keywords
- CAR γδ T cells, CD7 positive, Recurrent refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 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.
CD7 is highly expressed in T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma. Approximately 10-30% of cute myeloid leukemia(AML) patients exhibit CD7 expression, particularly in early myeloid progenitor cell-derived AML (e.g., M0/M1 subtypes), mixed-phenotype acute leukemia (MPAL), and AML with high-risk genetic abnormalities (such as TP53 mutations or complex karyotypes). CD7-positive AML patients typically have poor prognosis, poor response to standard chemotherapy, and shorter overall survival (OS). Targeted CD7 cell therapies may represent a promising direction for the treatment of these diseases.
Detailed description
This study is a single-arm,open-label, dose-escalation clinical trial. It is planned to enroll 9-18 patients with CD7-positive relapsed/refractory T-ALL/LBL and relapsed/refractory AML. The study will use a 3+3 design for dose escalation, with three initial dose groups: 1*10^8 CAR+ cells, 3*10^8 CAR+ cells, and 6*10^8 CAR+ cells.
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 relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia | Experimental | Biological: CD7 CAR-γδT cell（QH106）, Drug: Fludarabine (FLU), Drug: Cyclophosphamide (CTX) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 14 years, no gender restrictions;
- Diagnosed with TALL/LBL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2023.V2); or diagnosed with AML according to the NCCN Acute Myeloid Leukemia Clinical Practice Guidelines (2023.V6);
- Meet the criteria for relapsed or refractory T-ALL/LBL, including any of the following:
- Cytological confirmation of tumor cell immunophenotyping as CD7-positive during screening;
- Expected survival time exceeding 3 months;
Key exclusion criteria (16 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;
- Heart failure classified as NYHA functional class III or IV;
- Any of the following unstable cardiovascular conditions occurring within the past 6 months prior to screening (including but not limited to): unstable angina, cerebral ischemia or cerebrovascular accident, myocardial infarction, severe arrhythmias requiring medication (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes); Undergone coronary angioplasty, coronary artery stent implantation, or coronary artery bypass surgery; experienced thrombosis or embolism 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 |
|---|---|---|
| CD7 CAR-γδT cell（QH106）Allogenic CD7 CAR-γδT cell，Intravenous on day0; dose escalation (3+3) : dose 1 (1 × 10^8 CAR+ cells) , dose 2 (3 × 10^8CAR+ cells/kg，dose 3 (6× 10^8 CAR+ cells）; | Biological | Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia |
| Fludarabine (FLU)Intravenous fludarabine 30~50 mg/m^2/day on days-5, -4, and -3； | Drug | Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia |
| Cyclophosphamide (CTX)Intravenous cyclophosphamide 500~1000 mg/m^2/day on days -5, -4, and -3. | Drug | Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 12 months
AE is defined as any adverse medical event from the date of lymphocyte depletion chemotherapy to 12 months after QH106 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versus-host disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of QH106 up to 28 days
8 secondary outcomes
Pharmacodynamics: Peak level of cytokines in serum
Time frame: Up to 28 days after infusion
Pharmacokinetics: Persistence of QH106
Time frame: 12 months
Overall Response rate (ORR)
Time frame: 12 months
Negative remission rate of minimal residual disease (MRD) in leukemia
Time frame: 12 month
Duration of remission (DOR)
Time frame: 12 month
Leukemia-free survival period(LFS)
Time frame: 12 month
Overall survival (OS)
Time frame: 12 month
Immunogenicity: Proportion of subjects with anti drug antibody (ADA)
Time frame: 12 month
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 13 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 CD7 CAR-γδT cell（QH106）, Fludarabine (FLU) and Cyclophosphamide (CTX) in people with Leukemia, 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 20 inclusion and 16 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 13 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 (+86 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 Adverse Events (AEs) (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 13 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.