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Status unknownNCT04028440Updated Sep 26, 2019

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

An Early Phase 1 interventional study of Autologous γδT cells in Non-Hodgkin's Lymphoma, Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma and Chronic Lymphoblastic Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Non-Hodgkin's Lymphoma
  • Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma
  • Chronic Lymphoblastic Leukemia
  • Peripheral T Cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 γδT 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

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 γδT 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 γδT 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Autologous γδT cells

    Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions, single infusion intravenously at a target dose of 1\~2×10e9 γδT cells (constant dose).

    Biological: Autologous γδT cells

Interventions

  • BiologicalAutologous γδT cells

    Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 months

  2. Overall response rate (ORR)

    Rate of complete remission (CR) and partial remission (PR).

    Time frame: 28 days after infusion of γδT cells

Secondary outcomes

  1. 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.

    Time frame: 15 months

  2. 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.

    Time frame: 15 months

  3. 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.

    Time frame: 15 months

  4. 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.

    Time frame: 15 months

  5. 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.

    Time frame: 15 months

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital
    Tianjin, Tianjin 300020, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04028440
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
Beijing GD Initiative Cell Therapy Technology Co., Ltd., Chinese Academy of Medical Sciences
Responsible party
Zou Dehui (Chief physician, Institute of Hematology & Blood Diseases Hospital, China) — Principal investigator
First posted
Jul 22, 2019
Start date
Oct 2019 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Sep 26, 2019

Study contacts

Dehui Zou, Dr.
Contact
zoudehui@ihcams.ac.cn
86-022-23909283
Shuhua Yi, Dr.
Contact
yishuhua@ihcams.ac.cn
86-022-23909106
Dehui Zou, Dr.
principal investigator · Institute of Hematology & Blood Disease Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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