Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
NCT ID: NCT04764513
Last Updated: 2022-03-28
Study Results
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2021-09-12
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with hematological malignancies after allo-HSCT
1. Patients with negative minimal residual disease or stable disease:
After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
2. Patients with positive minimal residual disease but not hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
3. Patients with hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
Ex-vivo expanded γδ T cell infusion
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.
Interventions
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Ex-vivo expanded γδ T cell infusion
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age criteria: 18-65 years;
3. Weight criteria: \> 40kg;
4. 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;
5. Life expectancy of at least 4 months;
6. ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
7. Patients able to understand and sign written informed consent.
Exclusion Criteria
2. Thrombotic microangiopathy；
3. Posttransplant lymphoproliferative disorders；
4. Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
5. Patients with chronic diseases that require treatment with immune agents or hormones;
6. Suffering from systemic autoimmune disease or immunodeficiency disease;
7. Systemic use of steroids;
8. Allergic constitution;
9. Hemorrhagic disease or coagulation disorders;
10. Patients participating in other clinical trials within 30 days prior to enrollment;
11. Patients receiving radiotherapy within 4 weeks prior to enrollment;
12. Pregnant or breastfeeding women;
13. According to the researcher's judgment, the patient has other unsuitable conditions.
18 Years
65 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Han weidong
Professor
Principal Investigators
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Chunji Gao, Professor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Weidong Han, Professor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHN-PLAGH-BT-062
Identifier Type: -
Identifier Source: org_study_id
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