NCT04004637

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

June 28, 2019

Last Update Submit

September 25, 2020

Conditions

T-lymphoblastic LymphomaNK/T Cell LymphomaAcute Lymphocytic Leukemia

Keywords

NK/T cell lymphomaT-lymphoblastic lymphomaAcute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Identification of the dose limiting toxicity (DLT)

    Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.

    Time Frame: 4 weeks after CAR T cell infusion

Secondary Outcomes (5)

  • In vivo persistence/expansion of infused CAR T cell

    Up to 2 years

  • Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.

    Up to 2 years

  • Overall Response Rate (ORR)

    4 weeks after CAR T cell infusion

  • Overall Survival

    Up to 2 years

  • Disease-free survival

    Up to 2 years

Study Arms (1)

CD7 CAR-T cells Infusion

EXPERIMENTAL
Drug: CD7 CAR-T cells infusion

Interventions

CD7 CAR-T cells infusionDRUG

Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment. CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10\^6/kg.

CD7 CAR-T cells Infusion

Eligibility Criteria

Age7 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Aged 7 to 70 years.
  • \. The expected survival period is more than 12 weeks.
  • \. ECOG: 0-2.
  • \. 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:
  • Not achieved PR after the standard first-line treatment for at least 4 courses.
  • Relapse or progression after standardized treatment.
  • Patients With NK/T Cell Lymphoma or T-lymphoblastic Lymphoma need to have at least 1 tumor lesions can be evaluated.
  • \. Cardiac left ventricle ejection fraction ≥40%.
  • \. Serum creatinine≤1.5 ULN; oxygen saturation of blood \>91%.
  • \. Total bilirubin≤1.5×ULN; Serum ALT and AST≤2.5 ULN.
  • \. Able to understand this study and have signed informed consent.

You may not qualify if:

  • \. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
  • \. 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.
  • \. 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.
  • \. 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.
  • \. Unstable systemic diseases judged by investigator, including but not limited to severe liver, kidney or metabolic diseases needing medical treatment.
  • \. 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35435984DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphoma

Central Study Contacts

Mingzhi Zhang, Doctor

CONTACT

+8613838565629mingzhi_zhang@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

August 25, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

CN(1)