Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia

NCT07120607 | Not Yet Recruiting Phase 1

• 1 other identifier: QH10601-TAL-01（0）
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Leukemia

Keywords

CAR γδ T cells; CD7 positive; Recurrent refractory

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• Incidence of Dose-Limiting Toxicities (DLTs)

  First infusion date of QH106 up to 28 days

Secondary Outcomes (8)

• Pharmacodynamics: Peak level of cytokines in serum

  Up to 28 days after infusion

• Pharmacokinetics: Persistence of QH106

  12 months

• Overall Response rate (ORR)

  12 months

• Negative remission rate of minimal residual disease (MRD) in leukemia

  12 month

• Duration of remission (DOR)

  12 month

Study Arms (1)

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)

Interventions

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）;

Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia

Fludarabine (FLU) DRUG

Intravenous fludarabine 30\~50 mg/m\^2/day on days-5, -4, and -3；

Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia

Cyclophosphamide (CTX) DRUG

Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.

Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemia

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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%;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Leukemia

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Xiaoyu Zhu

CONTACT

+86 15255456091; xiaoyuz@ustc.edu.cn

Guangyu Sun

CONTACT

+86 13956970687; sunguangyu_vip@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 13, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08