- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208853
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells Injection (Anti CD30 CAR T Cells) in Patients With CD30+ Relapsed/Refractory Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-center, open-label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.
This study intends to include CD30-positive patients with relapsed/refractory CD30+ lymphoma, and subjects will receive a single injection of anti CD30 CAR-T cells after screening, Peripheral Blood Mononuclear Cell (PBMC) collection, and lymphodepletion chemotherapy pretreatment. Response assessments for lymphoma subjects will base on 2018 Lugano Classification.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Huang He, PhD
- Phone Number: 86-13605714822
- Email: hehuangyu@126.com
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital, College of Medicine, Zhejiang University
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Contact:
- Huang He, PhD
- Phone Number: 86-13605714822
- Email: hehuangyu@126.com
-
Contact:
- Yongxian Hu
- Phone Number: 86-15957162012
- Email: huyongxian2000@aliyun.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must meet all of the following criteria to be included in the group:
- Understand and sign the informed consent form, and voluntarily participate in clinical study;
- 18-70 years old, no gender limit;
Patients with CD30+ lymphoma have received at least 2-line systemic treatment in the past and who have relapsed or are refractory, including but not limited to:
- Hodgkins lymphoma;
- Mature T-cell lymphoma, including but not limited to non-specific peripheral T cell lymphoma, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large-cell lymphoma;
- Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma;
- Other lymphocytic proliferative tumors;
- Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1;
- Patients with sufficient venous access (for apheresis), and no other contraindications for blood cell separation;
- According to the revised version of the efficacy evaluation of malignant lymphoma (2018 lugano standard), Patients should be fluorodeoxyglucose-PET positive and with at least on measurement lesion: long axis of the lesion is ≥ 1.5 cm, or the long axis is 1.0-1.5 cm and short axis ≥1.0cm;
Patients should meet the following laboratory exam requirements during screening, and haven't received cell growth factor (long-acting colony stimulating factor (G-CSF/PEG-CSF) , requires an interval of 2 weeks, except for recombinant erythropoietin) within 7 days before hematological evaluation screening;
- The absolute value of neutrophils ≥ 1.0×10^9/L;
- Hemoglobin ≥ 90g/L (without red blood cell transfusion within 14 days), hemoglobin in patients with bone marrow involvement ≥ 75g/L;
- Platelets in patients without bone marrow involvement≥75×10^9/L, and patients in platelets with bone marrow involvement ≥ 50×10^9/L;
- Absolute lymphocyte (ALC) ≥ 0.3×10^9/L;
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (if the bilirubin level rises due to lymphoma invading the liver, allow its total bilirubin ≤ 3 × ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5×ULN; if AST, ALT elevation is caused by lymphoma invading the liver, allow its AST, ALT ≤ 5×ULN);
- Creatinine <1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL/min;
- There is no evidence that the subject has difficulty breathing at rest, and the measured pulse oximetry value when breathing room air is > 90%;
- Women of childbearing age must have a negative serum pregnancy test, and they must agree to take effective contraceptive methods at the same time from the signing of the informed consent form to 6 months after the last administration of the study drug.
Exclusion Criteria:
Patients cannot participate in this study if they meet any of the following conditions:
- Patients have a history of allergies to any component in cell therapy products.
- Patients received any CAR-T cell product or other genetically modified T cell therapy in the past.
- Patients received autologous or allogeneic hematopoietic stem cell transplantation within 3 months.
- Patients suffering from other malignant tumors in the past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years).
- Patients who have received continuous systemic steroids (prednisone> 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids.
- Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA > 10^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test).
- Patients with syphilis, human immunodeficiency virus (HIV) infection (HIV positive).
- Patients with hyponatremia and/or hypokalemia, blood sodium < 125 mmol/L and/or blood potassium < 3.5 mmol/L (Except that blood sodium and/or potassium were restored above this level by sodium and/or potassium supplementation before participating in this study).
- Patients was known or existing primary or metastatic central nervous system lymphoma, or with any other central nervous system disease (such as seizures, cerebral ischemia/hemorrhage, dementia, etc.).
- According to the heart function classification standard of New York Heart Association (NYHA), those with grade III or IV cardiac insufficiency; Cardiac ejection fraction is lower than 50% or lower than the lower limit of the laboratory test value range of the research center, or ECG is significantly abnormal.
- Patients with severe respiratory diseases at the time of enrollment (before apheresis), such as interstitial lung disease, active tuberculosis, etc., investigator considered unsuitable for enrollment.
- According to the judgment of the investigator, patients with any serious or uncontrollable systemic disease, systemic complications, other serious concurrent diseases (such as hematophilic syndrome, etc.), special tumor conditions may unsuitable for entering this study or affect Protocol compliance, or significant interference with the correct evaluation of the safety, toxicity, and effectiveness of the study drug.
- Major surgery has been performed within 4 weeks before apheresis (the definition of major surgery refers to the level 3 and level 4 surgery specified in the "Administrative Measures for the Clinical Application of Medical Technology");Or has not fully recovered from any previous invasive operation.
- Patients received systemic chemotherapy within 3 weeks before apheresis, or the toxicity of previous anti-tumor therapy has not recovered ( > CTCAE v5.0 grade 1), except for hair loss and pigmentation.
- Patients received Anti-CD30 and other anti-tumor antibody treatments within 4 weeks before apheresis.
- Patients received any previous systemic inhibitory/stimulatory immune checkpoint molecular therapy (anti-PD-1/PD-L1 monoclonal antibody), and within 3 half-lives.
- Patients have used immunostimulatory or immunosuppressive therapy (such as IFN-α, IFN-β, IL-2, etanercept, infliximab, tacrolimus, cyclosporine or mycophenolic acid) within 28 days before apheresis.
- Patients received short-acting targeted therapy (such as tyrosine kinase inhibitors) before apheresis and within 72 hours before infusion.
- Those who plan to undergo allogeneic/autologous hematopoietic stem cell transplantation during the study period after the investigators assessment.
- Those who have participated in other interventional clinical study before apheresis or within 1 month before administration.
- Women who are already pregnant, preparing for pregnant during the study, or breastfeeding.
- During the study period, women of childbearing age and men with fertility were unwilling or unable to use reliable contraceptive methods.
- Personnel involved in the research plan and implementation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anti CD30 CAR T cells
Patients receive anti CD30 CAR-T cells on day 0 after lymphodepleting treatment. Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to anti CD30 CAR-T cells infusion. |
After enrollment, subjects complete the apheresis, then complete the lymphodepletion, and then receive the dose escalation test: 1.5×10^7 cells,1.5×10^8 cells,5× 10^8 cells. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: within 4 weeks after infusion
|
Maximum Tolerated Dose
|
within 4 weeks after infusion
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AE and SAE
Time Frame: day 0 to month 12
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To evaluate safety of the cell therapy.
Adverse event and serious adverse event.
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day 0 to month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate, ORR
Time Frame: day 0 to month 12
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Proportion of subjects with complete or partial remission
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day 0 to month 12
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Disease control rate, DCR
Time Frame: day 0 to month 12
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The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
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day 0 to month 12
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Duration of remission, DOR
Time Frame: day 0 to month 12
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The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;
|
day 0 to month 12
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Progression-free survival, PFS
Time Frame: day 0 to month 12
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The time from cell reinfusion to the first assessment of tumor progression or death from any cause
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day 0 to month 12
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Overall survival, OS
Time Frame: day 0 to month 12
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The time from the cell reinfusion to death due to any cause.
|
day 0 to month 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Huang He, PhD, First affiliated Hospital of Zhejiang University
Study record dates
Study Major Dates
Study Start (Anticipated)
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, B-Cell
- Lymphadenopathy
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Large-Cell, Anaplastic
- Immunoblastic Lymphadenopathy
Other Study ID Numbers
- ARM002-CN-2021-01
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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