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Adult T-Cell Lymphoma/LeukaemiaPhase 1NCT04008394

Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies

A Phase 1 study testing Anti-CD30 CAR T cells in people with Adult T-Cell Lymphoma/Leukaemia and Anaplastic Large Cell Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The overall purpose of this study is to explore the safety and therapeutic effect of CD30-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Refractory/Relapsed lymphocyte malignancies. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anti-CD30 CAR T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
3 Jul 2019to 1 Jan 2023
Phase
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
  • Male or female patients aged 18 to 70 years (including 18 and 70 years old).
  • Pathological and histological examination confirmed CD30+ lymphocyte malignancies, and patients currently have no effective treatment options, such as chemotherapy or recurrence after hematopoietic stem cell transplantation; or patients voluntarily choose Anti-CD30 CAR-T as rescue treatment.
  • CD30+ lymphocyte malignancies:
  • Adult T-cell leukemia/lymphoma
  • Anaplastic large cell lymphoma (ALCL);
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  • Angioimmunoblastic T-cell Lymphoma (AITL);
  • NK/T-cell lymphoma;
  • Peripheral T-cell lymphoma (PTCL);
  • Hodgkin lymphoma;
  • Subjects:
  • There are still residual lesions after major treatment, and they are not suitable for HSCT (auto/allo-HSCT);
  • Recurrence occurs after CR1, and HSCT (auto/allo-HSCT) is not selected or suitable because of self-willingness;
  • After hematopoietic stem cell transplantation or cellular immunotherapy, the patient suffered relapse or did not remission.
  • Having a measurable or evaluable lesion.
  • Patient's main organs function well：
  • Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and
  • total bilirubin≤34.2μmol/L
  • Renal function: Creatinine < 220μmol/L.
  • Pulmonary function: Indoor oxygen saturation≥95%.
  • Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
  • The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to < 1 level at admission (except for low toxicity such as alopecia).
  • The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
  • Patient ECOG score≤2, Estimated survival time≥3 months.

Who cannot join

  • Women who are pregnant (urine/blood pregnancy test positive) or lactating.
  • Male or female with a conception plan in the past 1 years.
  • Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
  • Uncontrolled infectious disease within 4 weeks prior to enrollment.
  • Active hepatitis B/C virus.
  • HIV infected patients.
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  • Suffering from a serious autoimmune disease or immunodeficiency disease.
  • The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
  • The patient participated in other clinical trials within 6 weeks prior to enrollment.
  • Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
  • Have a history of epilepsy or other central nervous system diseases.
  • Having drug abuse/addiction.
  • According to the researcher's judgment, the patient has other unsuitable grouping conditions.

Trial locations and contacts

1 site in 1 country.

Yu Hu, M.D. Ph.D contact

86-13986183871

dr_huyu@126.com

Heng Mei, M.D. Ph.D contact

86-13886160811

hmei@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Yu Hu, M.D., Ph.D, 86-13986183871, dr_huyu@126.com

    Heng Mei, M.D., Ph.D, 86-13886160811, hmei@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies：a Single-center, Open, Single-arm Clinical Study.

The overall purpose of this study is to explore the safety and therapeutic effect of CD30-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Refractory/Relapsed lymphocyte malignancies.

Read the detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CD30 is originally described as a marker of Hodgkin's and R-S cells in Hodgkin's lymphoma. CD30 antibody has been applied to treat lymphocyte derived malignancies. To explore the potency of CD30 in CAR-T therapy, this trial is designed and conducted to test the safety and efficacy of CD30-targeted CAR-T in Refractory/Relapsed lymphocyte malignancies.

Being tested
Anti-CD30 CAR T cells
Keywords
CD-30 CART, Refractory/Relapsed, lymphocyte malignancies
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, Extranodal NK-T-Cell, Lymphoma, T-Cell, Peripheral, Hodgkin Disease, Recurrence

What participants receive

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

  • Anti-CD30 CAR T cellsGenetic

    Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.

Study groups in NCT04008394
Study groupRoleWhat they receive
Anti-CD30 CAR T cellsExperimentalPatients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.
Receives: Genetic: Anti-CD30 CAR T cells

What is being measured

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

  1. Number of participants with adverse events

    Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

    Measured: 3 years

Secondary outcomes (6)

  1. One-month remission rate

    Response to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015).

    Measured: 1 month

  2. Overall survival

    OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored).

    Measured: 3 years

  3. Event-free survival

    EFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).

    Measured: 3 years

  4. Relapse-free survival

    RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored).

    Measured: 3 years

  5. Quantity of anti-CD30 CAR-T cells in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry.

    Measured: 3 years

  6. Quantity of anti-CD30 CAR copies in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of anti-CD30 CAR copies were determined by means of qPCR.

    Measured: 3 years

Timeline

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

  1. First posted5 Jul 2019
  2. Study start3 Jul 2019
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jan 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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-center,Open,One-arm Clinical Study
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008394
Sponsor's protocol ID
WHUH-CART-CD30-01
Status last verified
Aug 2019
First submitted
2 Jul 2019
Last updated
7 Aug 2019
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 Phase 1 study testing Anti-CD30 CAR T cells in people with Adult T-Cell Lymphoma/Leukaemia and Anaplastic Large Cell Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 13 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 7 Aug 2019. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Yu Hu, M.D. Ph.D (86-13986183871, dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 3 years). 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 NCT04008394.

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 7 Aug 2019.

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