Status:
UNKNOWN
CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Conditions:
T Lymphoblastic Leukemia/Lymphoma
Extramedullary NK-T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
7-70 years
Phase:
PHASE1
Brief Summary
Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in...
Eligibility Criteria
Inclusion
- The age ranged from 7 to 70 years (including the cut-off value), regardless of gender
- The expected survival time was more than 6 weeks
- ECOG score 0-1
- Malignant lymphoma (including but not limited to acute T-lymphoblastic leukemia / lymphoma; extramedullary NK / T-cell lymphoma, nasal type; peripheral T-cell lymphoma, nonspecific; vascular immunoblastic T-cell lymphoma; intestinal disease associated T-cell lymphomas; anaplastic large cell lymphoma (ALK -); T-cell lymphoblastic leukemia)
- When screening, hematological malignancies with CD7 Positive confirmed by bone marrow examination or tumor pathology with positive rate of CD7 ≥ 30%, meeting one of the following conditions:
- At least two chemotherapy regimens failed or did not achieve complete remission or relapse;
- Patients who relapsed after stem cell transplantation were not affected by other treatment methods;
- For peripheral blood involved acute T-lymphoblastic leukemia / lymphoma and NK / T-cell lymphoma, patients with TCR rearrangement were detected by ngs
- The liver and kidney function, heart and lung function meet the following requirements:
- Creatinine ≤ 1.5 ULN;
- LVEF ≥ 45%;
- Blood oxygen saturation \> 91%;
- The total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; the abnormal ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction) can be relaxed to ≤ 5 × ULN;
- Understand the experiment and have signed the informed consent
Exclusion
- Those who need immunosuppressant;
- For intestinal disease-related T-cell lymphoma, patients with intestinal ulcer or hematochezia were examined by colonoscopy;
- In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
- The patients with positive HBsAg or HBcAb and HBV DNA titer in peripheral blood were not within the normal reference value; those with positive anti HCV antibody and positive HCV RNA in peripheral blood; those with HIV antibody positive and cytomegalovirus DNA positive Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
- Pregnant or lactating women, female subjects planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
- Patients who had received car-t therapy or other gene modified cell therapy before screening;
- Subjects who were receiving systemic steroid therapy or were receiving systemic steroid therapy for 7 days were excluded;
- Participated in other clinical studies within 3 months before screening;
- There was evidence of central nervous system invasion during screening;
- According to the judgment of the researchers, it does not conform to the condition of cell preparation;
- Other researchers think it is not suitable to be included in the study.
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04480788
Start Date
November 24 2020
End Date
August 31 2022
Last Update
January 6 2021
Active Locations (1)
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1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000