Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies

Fundamenta Therapeutics

Status and phase: Unknown; Phase 1

Conditions: T-Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; T-cell Non-Hodgkin Lymphoma

Treatments: Biological: ThisCART7 cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05127135

ThisCART7

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.);
2. No alternative treatment options deemed by investigator;
3. Measurable or detectble disease at time of enrollment;
4. Age 18-70 years old, no gender and race limited;
5. Eastern cooperative oncology group (ECOG) performance status of ≤2;
6. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
7. Estimated life expectancy > 12 weeks deemed by investigator;
8. Serum creatinine ≤ 1.5 upper limit of normal (ULN);
9. Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
10. Signed informed consent form (ICF).

Exclusion criteria

1. Women in pregnancy or lactation;
2. Uncontrolled infection;
3. Active hepatitis B virus or hepatitis C virus infection;
4. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
5. Prior treatment with an allogeneic stem cell transplant within 100 days;
6. Grade 2-4 Active graft versus host disease;
7. History of HIV infection;
8. With central nervous system involvement;
9. Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ThisCART7 cells injections

Experimental group

Description:

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.

Treatment:

Biological: ThisCART7 cells