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Status unknownNCT04004637Updated Sep 28, 2020

CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

A Phase 1 interventional study of CD7 CAR-T cells infusion in T-lymphoblastic Lymphoma, NK/T Cell Lymphoma and Acute Lymphocytic Leukemia, sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-28.

Sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
7 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • T-lymphoblastic Lymphoma
  • NK/T Cell Lymphoma
  • Acute Lymphocytic Leukemia

Keywords

  • NK/T cell lymphoma
  • T-lymphoblastic lymphoma
  • Acute Lymphocytic Leukemia
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Aged 7 to 70 years.

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

Exclusion criteria

Exclusion Criteria:

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

      1. 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.
      1. 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.
      1. 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.
      1. Unstable systemic diseases judged by investigator, including but not limited to severe liver, kidney or metabolic diseases needing medical treatment.
      1. 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.
      1. 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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    CD7 CAR-T cells Infusion

    Drug: CD7 CAR-T cells infusion

Interventions

  • DrugCD7 CAR-T cells infusion

    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.

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What researchers measure

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: Time Frame: 4 weeks after CAR T cell infusion

Secondary outcomes

  1. In vivo persistence/expansion of infused CAR T cell

    Detection of infused CAR T cell in the peripheral blood.

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  3. Overall Response Rate (ORR)

    Time frame: 4 weeks after CAR T cell infusion

  4. Overall Survival

    Time frame: Up to 2 years

  5. Disease-free survival

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35435984 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04004637
Lead sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators
The First Affiliated Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Aug 25, 2019
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
Sep 28, 2020

Study contacts

Mingzhi Zhang, Doctor
Contact
mingzhi_zhang@126.com
+8613838565629

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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