Clinical trial NCT04004637: CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia
Official title: CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T-lymphoblastic Lymphoma
NK/T Cell Lymphoma
Acute Lymphocytic Leukemia
Keywords: NK/T cell lymphoma
T-lymphoblastic lymphoma
Acute Lymphocytic Leukemia
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
First posted: 2019-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to explore the safety and efficacy of CD7 CAR-T Cells for patients with relapse/refractory CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia. And to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.


Eligibility criteria: Inclusion Criteria:

* 1. Aged 7 to 70 years.

  2. The expected survival period is more than 12 weeks.

  3. ECOG: 0-2.

  4. Male and female subjects with CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia in patients with no available curative treatment options will be enrolled:
  1. Not achieved PR after the standard first-line treatment for at least 4 courses.
  2. Relapse or progression after standardized treatment.
  3. Patients With NK/T Cell Lymphoma or T-lymphoblastic Lymphoma need to have at least 1 tumor lesions can be evaluated.

  5. Cardiac left ventricle ejection fraction ≥40%.

  6. Serum creatinine≤1.5 ULN; oxygen saturation of blood \>91%.

  7. Total bilirubin≤1.5×ULN; Serum ALT and AST≤2.5 ULN.

  8. Able to understand this study and have signed informed consent.

Exclusion Criteria:

* 1. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.

  2. Patients with malignant tumors other than NK/T cell lymphoma , T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, local prostate after radical surgery, breast ductal carcinoma in situ after cancer and radical surgery.

  3. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.

  4. Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ III), severe arrhythmia.

  5. Unstable systemic diseases judged by investigator, including but not limited to severe liver, kidney or metabolic diseases needing medical treatment.

  6. Active or uncontrollable infections (except for mild genitourinary infections and upper respiratory tract infections) that require systemic treatment within 7 days prior to screening; 7. Women who are pregnant or breastfeeding, female subject who plans to have a pregnancy within 1 year after cell infusion, and male subject who plans to have a pregnancy within 1 year after cell infusion.

  8. Subject who have received CAR-T treatment or other genetically modified cell therapy before screening; 9. Subjects who are receiving systemic steroid therapy within 7 days prior to screening or who require long-term systemic steroid therapy judged by investigator (except for inhaled or topical use); 10. Participated in other clinical studies within 3 months prior to screening. 11. Patients with active CNS involvement by malignancy. 12. Not suitable for cell preparation. 13. Researchers consider it inappropriate to participate in the trial.

Primary outcomes:
measure: Identification of the dose limiting toxicity (DLT)
timeFrame: Time Frame: 4 weeks after CAR T cell infusion
Secondary outcomes:
measure: In vivo persistence/expansion of infused CAR T cell
timeFrame: Up to 2 years
measure: Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.
timeFrame: Up to 2 years
measure: Overall Response Rate (ORR)
timeFrame: 4 weeks after CAR T cell infusion
measure: Overall Survival
timeFrame: Up to 2 years
measure: Disease-free survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
citation: Zhang M, Chen D, Fu X, Meng H, Nan F, Sun Z, Yu H, Zhang L, Li L, Li X, Wang X, Wang M, You F, Li Z, Chang Y, Zhou Z, Yan J, Li J, Wu X, Wang Y, Wang Y, Xiang S, Chen Y, Pan G, Xu H, Zhang B, Yang L. Autologous Nanobody-Derived Fratricide-Resistant CD7-CAR T-cell Therapy for Patients with Relapsed and Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma. Clin Cancer Res. 2022 Jul 1;28(13):2830-2843. doi: 10.1158/1078-0432.CCR-21-4097.