Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT

Phase 1

Recruiting

• Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Lymphoma
• Interventions: Biological: Ex-vivo expanded γδ T cell infusion

• Registration Number: NCT04764513
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-09-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28
• Primary Completion: 2023-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with hematological malignancies after allo-HSCT	Ex-vivo expanded γδ T cell infusion	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]	Day 28 after completion of treatment	Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients reaching Complete Remission (CR) [Efficacy]	12 months post-treatment	Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR).
Quality of Life (QoL)	12 months post-treatment	Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.
Overall Survival (OS) [Efficacy]	12 months post-treatment	Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
Persistence of γδ T cell	Before treatment and up to 3 months after treatment	Persistence of γδ T cell assessed by number in peripheral blood.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China