Clinical trial NCT04764513: Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Official title: Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes
Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×10\^6、 1×10\^7/kg and 5×10\^7 of cells per kg of body weight). The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
Primary purpose: TREATMENT

Brief summary: This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.

Detailed description: This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
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:

1. GVHD (graft versus host disease) ≥ grade Ⅱ；
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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
timeFrame: Day 28 after completion of treatment
measure: Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
timeFrame: Day 28 after completion of treatment
Secondary outcomes:
measure: Number of patients reaching Complete Remission (CR) [Efficacy]
timeFrame: 12 months post-treatment
measure: Overall Survival (OS) [Efficacy]
timeFrame: 12 months post-treatment
measure: Quality of Life (QoL)
timeFrame: 12 months post-treatment
measure: Persistence of γδ T cell
timeFrame: Before treatment and up to 3 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Chunji Gao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Weidong Han, Professor
role: PRINCIPAL_INVESTIGATOR
References: