Clinical trial NCT05127135: Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
Official title: A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: T-Acute Lymphoblastic Leukemia
T-cell Non-Hodgkin Lymphoma
T-cell Acute Lymphoblastic Lymphoma
Lead sponsor: Fundamenta Therapeutics, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of University of Science and Technology of China
First posted: 2021-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-related grade≥3Adverse Events or SAE
timeFrame: within 4 weeks after infusion
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 4 to 6 weeks after infusion
Other outcomes:
measure: Progression free survival time
timeFrame: 3 years
measure: Overall survival time
timeFrame: 3 years
measure: Event-free survival
timeFrame: 3 years
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
state: Anhui
city: Suzhou
country: China
facility: Fundamenta Therapeutice Co.,Ltd
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Wang Xingbing
role: PRINCIPAL_INVESTIGATOR
References: