Health TrialsbyHealthPanel

Allogeneic CD7 CAR γδ T Cells Therapy Recurrent/Refractory Leukemia

ConditionLeukemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14+
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD7 CAR-γδT cell（QH106）

    Biological/Vaccine

    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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Patients with relapsed/refractory acute T-cell leukemia/lymphoma and acute myeloid leukemiaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

Incidence of Dose-Limiting Toxicities (DLTs)

Time frame
First infusion date of QH106 up to 28 days

Secondary outcomes

1

Pharmacodynamics: Peak level of cytokines in serum

Time frame
Up to 28 days after infusion
2

Pharmacokinetics: Persistence of QH106

Persistence of QH106 assessed by number in peripheral blood

Time frame
12 months
3

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)

Time frame
12 months
4

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

Time frame
12 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: