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

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.

Study Overview

• Status: Recruiting
• Conditions: T-Acute Lymphoblastic Leukemia; T-cell Non-Hodgkin Lymphoma; T-cell Acute Lymphoblastic Lymphoma
• Intervention / Treatment: Biological: ThisCART7 cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Jun, Ph.D; Phone Number: +86-18662604088; Email: jli@ctigen.com
• Study Contact Backup: Name: He Ling; Phone Number: +86-18626100886; Email: lhe@ctigen.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • Fundamenta Therapeutice Co.,Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ThisCART7 cells injections; 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.	Biological: ThisCART7 cells; 0.5-6 x 10^6 CAR T cells per kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival time	The interval between administration and disease progression or death.	3 years
Overall survival time	The interval between administration and death caused by any reason.	3 years
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

Collaborators and Investigators

• Sponsor: Fundamenta Therapeutics, Ltd.
• Collaborators: The First Affiliated Hospital of University of Science and Technology of China
• Investigators: Principal Investigator: Wang Xingbing, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ANTICIPATED): January 24, 2023
• Study Completion (ANTICIPATED): December 24, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (ACTUAL): November 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: ThisCART7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No