Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients

NCT04696705 | Unknown Early Phase 1

• 1 other identifier: IIT2020028-EC-3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Conditions

Non-Hodgkin's Lymphoma (NHL); Peripheral T Cell Lymphoma (PTCL)

Outcome Measures

Primary Outcomes (3)

• Safety evaluation: Incidence of Adverse events (AEs)

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  2 years post γδT cells infusion

• Safety evaluation: Dose limited toxicity (DLTs)

  The incidence of DLTs will be recorded and assessed.

  28 days

• Safety evaluation: Maximum-tolerated dose (MTD)

  MTD or clinical recommended dose will be recorded and evaluated.

  28 days

Secondary Outcomes (6)

• Efficacy evaluation：Overall response rate (ORR)

  2 years post γδT cells infusion

• Efficacy evaluation：Disease control rate (DCR)

  2 years post γδT cells infusion

• Efficacy evaluation：Duration of remission (DOR)

  2 years post γδT cells infusion

• Efficacy evaluation：Progression free survival (PFS)

  2 years post γδT cells infusion

• Efficacy evaluation：Overall survival (OS)

  2 years post γδT cells infusion

Study Arms (1)

Allogeneic γδT cell immunotherapy

EXPERIMENTAL

Patients will receive 2 cycles of ex-vivo expanded allogeneic γδT cells treatments, at 14 days' intervals, each cycle has 2 infusions. Ex-vivo expanded γδT cells are transfused to patients in a dosage escalated manner (Dose escalation, 1×107, 3×107, 9×107 per kg of body weight).

Biological: Ex-vivo expanded allogeneic γδT cells

Interventions

Ex-vivo expanded allogeneic γδT cells BIOLOGICAL

Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

Allogeneic γδT cell immunotherapy

Eligibility Criteria

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

You may qualify if:

• Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
• Age≥18 years old, gender unlimited.
• Patients whose relatives are willing to donate PBMCs voluntarily.
• Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
• Patients had an evaluable imaging lesion of at least greater than 1.5 cm.
• Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) \>1000/mm3;
• Absolute lymphocyte count (ALC)≥300/mm3;
• PLT≥50,000/mm3;
• Hb \>8.0g/dl.
• Adequate organ function:
• Alanine aminotransferase (ALT)≤3 times the upper limit of normal (ULN);
• Aspartate aminotransferase (AST)≤3 times ULN
• TBIL≤1.5 times ULN (Gilbert syndrome patients TBIL≤3 times ULN and DBIL≤1.5 times ULN)

You may not qualify if:

• Patients with other available treatment drugs or treatment options.
• Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
• Active central nervous system (CNS) lymphoma.
• Patients receiving chemotherapy within 1 week prior to γδT cell transfusion, with the following exceptions:
• Pretreatment chemotherapy prescribed by the protocol
• Other exploratory combined medications
• Systemic glucocorticoid treatment 72h prior to γδT cell transfusion (apart from physiological replacement dosage).
• Biphosphonates were used 2 months prior to γδT cell transfusion.
• Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
• Active HBV, HCV, HIV, TP, CMV or EBV infection.
• Patients with malignant tumors, apart from those who has been cured for at least 2 years.
• Patient's cardiac function meets any of the following conditions:
• Left ventricular ejection fraction (LVEF)≤45%
• Class III or IV heart failure according to the NYHA Heart Failure Classifications
• QTcB\>450 msec

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Beijing GD Initiative Cell Therapy Technology Co., Ltd.: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Institute of Hematology & Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Study Officials

• Jianmin Zhang, PhD

  Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Dehui Zou, MD

CONTACT

86-022-23909283; zoudehui@ihcams.ac.cn

Wei Liu, MD

CONTACT

86-022-23909282; liuwei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of lymphoma Diagnosis and Treatment Center

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: December 31, 2020
• Primary Completion: December 25, 2021
• Study Completion: December 25, 2023
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)