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

T-cell Non-Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127135
• Other study ID #: ThisCART7
• Status: Recruiting
• Phase: Phase 1
• Start date: January 22, 2020
• Est. completion date: December 24, 2023

Study information

• Verified date: November 2021
• Source: Fundamenta Therapeutics, Ltd.
• Contact: Li Jun, Ph.D
• Phone: +86-18662604088
• Email: jli[@]ctigen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T-Acute Lymphoblastic Leukemia
• T-cell Acute Lymphoblastic Lymphoma
• T-cell Non-Hodgkin Lymphoma

Intervention

Biological:
• ThisCART7 cells
0.5-6 x 10^6 CAR T cells per kg body weight

Locations

Country	Name	City	State
China	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)	Hefei	Anhui
China	Fundamenta Therapeutice Co.,Ltd	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Fundamenta Therapeutics, Ltd.	The First Affiliated Hospital of University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival time	The interval between administration and disease progression or death.	3 years
Other	Overall survival time	The interval between administration and death caused by any reason.	3 years
Other	Event-free survival	EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.	3 years
Primary	Incidence of Treatment-related grade=3Adverse Events or SAE	Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).	within 4 weeks after infusion
Secondary	Objective Response Rate	Description: For T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ; For lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria.	4 to 6 weeks after infusion