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Non-Hodgkin's Lymphoma (NHL)Early Phase 1NCT04696705

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

A Early Phase 1 study testing Ex-vivo expanded allogeneic γδT cells in people with Non-Hodgkin's Lymphoma (NHL) and Peripheral T Cell Lymphoma (PTCL), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ex-vivo expanded allogeneic γδT cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
31 Dec 2020to 25 Dec 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient Inclusion Criteria:
  • 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.
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  • 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)
  • Scr≤1.5 times ULN or CCR≥60 mL/min/1.73m3 Note: apart from tumor infiltrated liver dysfunction.
  • Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.
  • Donor Inclusion Criteria:
  • Sign informed consent form.
  • Age 18 years up to the age of 60 (≤60), gender unlimited.
  • Relatives of patients (unrestricted to blood relationship).
  • Apheresis available.
  • PLT≥100×109/L with normal APTT or PT.

Who cannot join

  • Patient Exclusion Criteria:
  • 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
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  • 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.
  • Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.
  • 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
  • Other cardiac disease that investigators judge is not suitable for enrollment
  • History of epilepsy or other active central nervous system disorders.
  • Inoculated live vaccine within 6 weeks before screening.
  • Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).
  • Life expectancy < 3 months
  • Participated in any other interventional clinical trial within 3 months prior to γδT cell transfusion.
  • Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed: patients with any serious acute or chronic physical or mental illness, or laboratory abnormalities.
  • Donor Exclusion Criteria:
  • History of any severe clinical diseases or other severe organic diseases, including any history of clinically significant systematic diseases such as cardiovascular, urinary, circulatory, respiratory, neurological, psychiatric, digestive and endocrine diseases. History of high blood pressure or systolic pressure>140 mmHg, diastolic pressure>90 mmHg in screening stage. Any situation that investigators believe is clinically significant or with other severe diseases unsuitable of apheresis.
  • Arterial thrombosis or venous thrombosis history 12 months prior to the trial or hemorrhagic tendency or history 2 months prior to the trial; oral administration of anticoagulation drugs (e. g. aspirin and warfarin).
  • Active or history of autoimmune diseases including but not restricted to SLE, psoriasis, RA, IBD and HT. Apart from hypothyrosis which can be controlled by hormone replacement therapy, skin diseases without systemic therapy and celiac disease which is fully controlled.
  • HIV-Ab, TP-Ab, HCV-Ab, HBsAg, HBeAg, HBeAb or HBcAb positive.
  • Any symptom, sign or laboratory examination abnormality suggesting acute or subacute infection (e.g. fever, cough, urinary irritation, skin infectious wound).
  • Female who are pregnant or cannot stop lactating.
  • Those who cannot communicate with medical staff due to mental illness or language disabilities.
  • Other unsuitable conditions that investigators believe unsuitable for the donation.

Trial locations and contacts

1 site in 1 country.

Dehui Zou, MD contact

86-022-23909283

zoudehui@ihcams.ac.cn

Wei Liu, MD contact

86-022-23909282

liuwei@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Disease Hospital

    Tianjin, Tianjin Municipality, 300020

    Wei Liu, MD, 86-022-23909282, liuwei@ihcams.ac.cn

    Shuhua Yi, MD, 86-022-23909106, yishuhua@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy Assessment of Ex-Vivo Expanded Allogeneic γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) and Peripheral T Cell Lymphomas (PTCL)

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.

Read the detailed description

This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from a blood-related donor of NHL or PTCL patients(except for γδT lymphoma). This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatments and follow-ups. The study will evaluate the safety and efficacy of the ex-vivo expanded allogeneic γδT cells in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Being tested
Ex-vivo expanded allogeneic γδT cells
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ex-vivo expanded allogeneic γδT cellsBiological

    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.

Study groups in NCT04696705
Study groupRoleWhat they receive
Allogeneic γδT cell immunotherapyExperimentalPatients 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).
Receives: Biological: Ex-vivo expanded allogeneic γδT cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 years post γδT cells infusion

  2. Safety evaluation: Dose limited toxicity (DLTs)

    The incidence of DLTs will be recorded and assessed.

    Measured: 28 days

  3. Safety evaluation: Maximum-tolerated dose (MTD)

    MTD or clinical recommended dose will be recorded and evaluated.

    Measured: 28 days

Secondary outcomes (6)

  1. Efficacy evaluation：Overall response rate (ORR)

    ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.

    Measured: 2 years post γδT cells infusion

  2. Efficacy evaluation：Disease control rate (DCR)

    DCR is defined as the incidence of either a CR, a partial response (PR) or stable disease (SD) per the Lugano Classification as determined by study investigators.

    Measured: 2 years post γδT cells infusion

  3. Efficacy evaluation：Duration of remission (DOR)

    DOR is defined only for participants who experience an objective response after γδT cells infusion and is the time from the first objective response to disease progression or death from any cause.

    Measured: 2 years post γδT cells infusion

  4. Efficacy evaluation：Progression free survival (PFS)

    PFS is defined as the time from the γδT cells infusion date to the date of disease progression or death from any cause.

    Measured: 2 years post γδT cells infusion

  5. Efficacy evaluation：Overall survival (OS)

    OS is defined as the time from γδT cells infusion to the date of death from any cause.

    Measured: 2 years post γδT cells infusion

  6. Pharmacokinetics (PK) evaluation :γδT cells in peripheral blood

    Number of γδT cells in peripheral blood will be assessed by flow cytometry.

    Measured: 2 years post γδT cells infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start31 Dec 2020
  3. Primary completion25 Dec 2021 (estimated)
  4. Study completion25 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696705
Sponsor's protocol ID
IIT2020028-EC-3
Status last verified
Jan 2021
First submitted
23 Dec 2020
Last updated
6 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ex-vivo expanded allogeneic γδT cells in people with Non-Hodgkin's Lymphoma (NHL) and Peripheral T Cell Lymphoma (PTCL), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dehui Zou, MD (86-022-23909283, zoudehui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation: Incidence of Adverse events (AEs) (time frame: 2 years post γδT cells infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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