- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127135
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
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
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.);
- No alternative treatment options deemed by investigator;
- Measurable or detectble disease at time of enrollment;
- Age 18-70 years old, no gender and race limited;
- Eastern cooperative oncology group (ECOG) performance status of ≤2;
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
- Estimated life expectancy > 12 weeks deemed by investigator;
- Serum creatinine ≤ 1.5 upper limit of normal (ULN);
- Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
- Signed informed consent form (ICF).
Exclusion Criteria:
- Women in pregnancy or lactation;
- Uncontrolled infection;
- Active hepatitis B virus or hepatitis C virus infection;
- Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
- Prior treatment with an allogeneic stem cell transplant within 100 days;
- Grade 2-4 Active graft versus host disease;
- History of HIV infection;
- With central nervous system involvement;
- 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
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.
|
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
Time Frame: within 4 weeks after infusion
|
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
Time Frame: 4 to 6 weeks after infusion
|
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
Time Frame: 3 years
|
The interval between administration and disease progression or death.
|
3 years
|
Overall survival time
Time Frame: 3 years
|
The interval between administration and death caused by any reason.
|
3 years
|
Event-free survival
Time Frame: 3 years
|
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
Investigators
- Principal Investigator: Wang Xingbing, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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