γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028440
• Other study ID #: QT2019001-EC-2
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2019
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Dehui Zou, Dr.
• Phone: 86-022-23909283
• Email: zoudehui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Description:

This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up. The study will evaluate the safety and efficacy of the autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients should sign informed consent form voluntarily.

2. Gender unlimited, age = 18 years old.

3. Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma(PTCL) expect for ?dT lymphoma.

4. Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).

5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

6. Adequate bone marrow function as defined by:Absolute neutrophil count (ANC) >1000/mm3;Absolute lymphocyte count (ALC) =300/mm3;Platelet =50000/mm3;Hemoglobin >8.0g/dl.

7. Adequate end organ function as defined by: Total bilirubin = 2 x upper limit of normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 x ULN; Creatinine = 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of = 60ml/min.

8. Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.

Exclusion Criteria:

1. Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).

2. Active central nervous system (CNS) lymphoma; Patients with symptoms of CNS disease must undergo lumbar puncture and brain nuclear magnetic resonance to exclude CNS lymphoma.

3. Patients receiving chemotherapy within 2 weeks prior to ?dT cell infusion, with the following exceptions:

• Pretreatment chemotherapy prescribed by the protocol

• In order to prevent CNS intrathecal chemotherapy (should be stopped 1 week before ?dT cell therapy)

• Other exploratory combined medications

4. Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.

5. Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV infection.

6. Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.

7. History of other malignant tumors, with the following exceptions

• Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)

• Cured situ carcinoma (e.g. cervical carcinoma)

• Localized prostate cancer with radiotherapy or surgery

• Patients with a history of malignant tumors, but the disease has been cured for =2 years

8. 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

• Other cardiac disease that investigators judge is not suitable for enrollment

9. History of epilepsy or other active central nervous system disorders.

10. Inoculated live vaccine within 6 weeks before screening.

11. Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).

12. Patients are allergic to cytokines.

13. Expected survival < 12 weeks.

14. Participated in any other interventional clinical trial within three months.

15. Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.

Related Conditions & MeSH terms

• Chronic Lymphoblastic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell, Peripheral
• Non-Hodgkin's Lymphoma
• Peripheral T Cell Lymphoma
• Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma

Intervention

Biological:
• Autologous ?dT cells
Cells will be extracted by apheresis, followed by expanding and activating. The autologous ?dT cells product will be adoptive transferred.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital	Beijing GD Initiative Cell Therapy Technology Co.,Ltd., Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Severe/Adverse Events as a Measure of Safety.	Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.	15 months
Primary	Overall response rate (ORR)	Rate of complete remission (CR) and partial remission (PR).	28 days after infusion of ?dT cells
Secondary	Duration of remission (DOR)	Duration of remission is defined as the time from the first occurrence of CR or PR in the tumor assessment to the first occurrence of disease progression (PD) or death.	15 months
Secondary	Time to response(TTR)	Time to response is defined as the time from the first administration of trial drug to the first occurrence of CR or PR in the tumor assessment.	15 months
Secondary	Disease control rate (DCR)	Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.	15 months
Secondary	Progression free survival (PFS)	Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.	15 months
Secondary	Overall survival (OS)	Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.	15 months