Clinical trial NCT04762485: Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
Official title: Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: T Lymphoblastic Leukemia/Lymphoma
Mixed Phenotype Acute Leukemia
Acute Myeloid Leukemia
Keywords: CD7 Positive
CAR-T
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.

Detailed description: The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed CD7 positive relapsed/refractory acute leukemia.
2. Age 12-65 years.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. CD7 on leukemia is \>30% positive detected with flow cytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.

Exclusion Criteria:

1. Patients are pregnant or lactating
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 2 years
measure: the duration of CAR T-cells in vivo
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: (Select)
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: xiaowen tang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6.