Trial | NCT05127135  Report issue

Title

Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    30
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
Study Started
Jan 22
2020
Primary Completion
Jan 24
2023
Anticipated
Study Completion
Dec 24
2023
Anticipated
Last Update
Nov 19
2021

Biological ThisCART7 cells

0.5-6 x 10^6 CAR T cells per kg body weight

ThisCART7 cells injections Experimental

In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.

Criteria 

Inclusion Criteria:

Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
No alternative treatment options deemed by investigator;
Measurable or detectble disease at time of enrollment;
Age 18-70 years old, no gender and race limited;
Eastern cooperative oncology group (ECOG) performance status of ≤2;
Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
Estimated life expectancy > 12 weeks deemed by investigator;
Serum creatinine ≤ 1.5 upper limit of normal (ULN);
Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
Signed informed consent form (ICF).

Exclusion Criteria:

Women in pregnancy or lactation;
Uncontrolled infection;
Active hepatitis B virus or hepatitis C virus infection;
Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
Prior treatment with an allogeneic stem cell transplant within 100 days;
Grade 2-4 Active graft versus host disease;
History of HIV infection;
With central nervous system involvement;
Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.
No Results Posted