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

NCT04764513 | Unknown Phase 1

• 1 other identifier: CHN-PLAGH-BT-062
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]

  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.

  Day 28 after completion of treatment

• Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]

  Tolerability of γδ 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 Outcomes (4)

• Number of patients reaching Complete Remission (CR) [Efficacy]

  12 months post-treatment

• Overall Survival (OS) [Efficacy]

  12 months post-treatment

• Quality of Life (QoL)

  12 months post-treatment

• Persistence of γδ T cell

  Before treatment and up to 3 months after treatment

Study Arms (1)

Patients with hematological malignancies after allo-HSCT

EXPERIMENTAL

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.

Biological: Ex-vivo expanded γδ T cell infusion

Interventions

Ex-vivo expanded γδ T cell infusion BIOLOGICAL

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.

Also known as: Chemotherapy

Patients with hematological malignancies after allo-HSCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Lymphoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chunji Gao, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Weidong Han, Professor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wei, Master

CONTACT

+86-13146682665; 13146682665@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: September 12, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2025
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

CN (1)