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

Lymphoma Clinical Trial

Official title:

Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764513
• Other study ID #: CHN-PLAGH-BT-062
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 12, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2022
• Source: Chinese PLA General Hospital
• Contact: Yan Wei, Master
• Phone: +86-13146682665
• Email: 13146682665[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?;

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• Ex-vivo expanded ?d T cell infusion
Phase 1: Patients receive ex-vivo expanded ?d 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 ?d T cell at the maximum tolerated dose determined in Phase 1.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]	Safety of ?d T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Day 28 after completion of treatment
Primary	Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]	Tolerability of ?d T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Day 28 after completion of treatment
Secondary	Number of patients reaching Complete Remission (CR) [Efficacy]	Efficacy of ex-vivo expanded ?d T cell assessed by number of patients reaching Complete Remission (CR).	12 months post-treatment
Secondary	Overall Survival (OS) [Efficacy]	Efficacy of ex-vivo expanded ?d T cell assessed by overall survival (OS) measured in months.	12 months post-treatment
Secondary	Quality of Life (QoL)	Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.	12 months post-treatment
Secondary	Persistence of ?d T cell	Persistence of ?d T cell assessed by number in peripheral blood.	Before treatment and up to 3 months after treatment