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

NCT ID: NCT05127135

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2023-12-24

Brief Summary

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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

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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.

Conditions

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T-Acute Lymphoblastic Leukemia T-cell Non-Hodgkin Lymphoma T-cell Acute Lymphoblastic Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ThisCART7 cells

Intervention Type BIOLOGICAL

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

Interventions

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ThisCART7 cells

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of University of Science and Technology of China

OTHER

Sponsor Role collaborator

Fundamenta Therapeutics, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang Xingbing

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

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The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

Site Status RECRUITING

Fundamenta Therapeutice Co.,Ltd

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Jun, Ph.D

Role: CONTACT

Phone: +86-18662604088

Email: [email protected]

He Ling

Role: CONTACT

Phone: +86-18626100886

Email: [email protected]

Facility Contacts

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Xingbing Wang

Role: primary

Jun Li

Role: primary

Ling He

Role: backup

Other Identifiers

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ThisCART7

Identifier Type: -

Identifier Source: org_study_id