- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04764513
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Yan Wei, Master
- Phone Number: +86-13146682665
- Email: 13146682665@163.com
Study Locations
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-
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Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
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Contact:
- Yan Wei, Master
- Phone Number: +86-13146682665
- Email: 13146682665@163.com
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Contact:
- Chunji Gao, Professor
- Phone Number: +86-13911536256
- Email: gaochunji301@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation;
- Age criteria: 18-65 years;
- Weight criteria: > 40kg;
Organ function criteria:
Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
- Life expectancy of at least 4 months;
- ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
- Patients able to understand and sign written informed consent.
Exclusion Criteria:
- GVHD (graft versus host disease) ≥ grade Ⅱ;
- Thrombotic microangiopathy;
- Posttransplant lymphoproliferative disorders;
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician);
- Patients with chronic diseases that require treatment with immune agents or hormones;
- Suffering from systemic autoimmune disease or immunodeficiency disease;
- Systemic use of steroids;
- Allergic constitution;
- Hemorrhagic disease or coagulation disorders;
- Patients participating in other clinical trials within 30 days prior to enrollment;
- Patients receiving radiotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women;
- According to the researcher's judgment, the patient has other unsuitable conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patients with hematological malignancies after allo-HSCT
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. |
Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10^6、 1×10^7 and 5×10^7 of cells per kg of body weight). Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Time Frame: Day 28 after completion of treatment
|
Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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Day 28 after completion of treatment
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Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Time Frame: Day 28 after completion of treatment
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Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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Day 28 after completion of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients reaching Complete Remission (CR) [Efficacy]
Time Frame: 12 months post-treatment
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Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR).
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12 months post-treatment
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Overall Survival (OS) [Efficacy]
Time Frame: 12 months post-treatment
|
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
|
12 months post-treatment
|
Quality of Life (QoL)
Time Frame: 12 months post-treatment
|
Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.
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12 months post-treatment
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Persistence of γδ T cell
Time Frame: Before treatment and up to 3 months after treatment
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Persistence of γδ T cell assessed by number in peripheral blood.
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Before treatment and up to 3 months after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chunji Gao, Professor, Chinese PLA General Hospital
- Principal Investigator: Weidong Han, Professor, Chinese PLA General 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
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Leukemia, Lymphoid
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Other Study ID Numbers
- CHN-PLAGH-BT-062
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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