AzTrials
AzTrials

Hodgkin LymphomaEarly Phase 1NCT05208853

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

A Early Phase 1 study testing Anti CD30 CAR-T Cell Injection in people with Hodgkin Lymphoma and NK/T Cell Lymphoma, run by Zhejiang University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Anti CD30 CAR-T Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
10 Feb 2022to 10 Feb 2022
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria to be included in the group:
  • Understand and sign the informed consent form, and voluntarily participate in clinical study;
  • 18-70 years old, no gender limit;
  • Patients with CD30+ lymphoma have received at least 2-line systemic treatment in the past and who have relapsed or are refractory, including but not limited to:
  • Hodgkins lymphoma;
  • Mature T-cell lymphoma, including but not limited to non-specific peripheral T cell lymphoma, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large-cell lymphoma;
Show all 21Show fewer
  • Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma;
  • Other lymphocytic proliferative tumors;
  • Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1;
  • Patients with sufficient venous access (for apheresis), and no other contraindications for blood cell separation;
  • According to the revised version of the efficacy evaluation of malignant lymphoma (2018 lugano standard), Patients should be fluorodeoxyglucose-PET positive and with at least on measurement lesion: long axis of the lesion is ≥ 1.5 cm, or the long axis is 1.0-1.5 cm and short axis ≥1.0cm;
  • Patients should meet the following laboratory exam requirements during screening, and haven't received cell growth factor (long-acting colony stimulating factor (G-CSF/PEG-CSF) , requires an interval of 2 weeks, except for recombinant erythropoietin) within 7 days before hematological evaluation screening;
  • The absolute value of neutrophils ≥ 1.0×10^9/L;
  • Hemoglobin ≥ 90g/L (without red blood cell transfusion within 14 days), hemoglobin in patients with bone marrow involvement ≥ 75g/L;
  • Platelets in patients without bone marrow involvement≥75×10^9/L, and patients in platelets with bone marrow involvement ≥ 50×10^9/L;
  • Absolute lymphocyte (ALC) ≥ 0.3×10^9/L;
  • Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (if the bilirubin level rises due to lymphoma invading the liver, allow its total bilirubin ≤ 3 × ULN);
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5×ULN; if AST, ALT elevation is caused by lymphoma invading the liver, allow its AST, ALT ≤ 5×ULN);
  • Creatinine <1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL/min;
  • There is no evidence that the subject has difficulty breathing at rest, and the measured pulse oximetry value when breathing room air is > 90%;
  • Women of childbearing age must have a negative serum pregnancy test, and they must agree to take effective contraceptive methods at the same time from the signing of the informed consent form to 6 months after the last administration of the study drug.

Who cannot join

  • Patients cannot participate in this study if they meet any of the following conditions:
  • Patients have a history of allergies to any component in cell therapy products.
  • Patients received any CAR-T cell product or other genetically modified T cell therapy in the past.
  • Patients received autologous or allogeneic hematopoietic stem cell transplantation within 3 months.
  • Patients suffering from other malignant tumors in the past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years).
  • Patients who have received continuous systemic steroids (prednisone> 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids.
Show all 24Show fewer
  • Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA > 10^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test).
  • Patients with syphilis, human immunodeficiency virus (HIV) infection (HIV positive).
  • Patients with hyponatremia and/or hypokalemia, blood sodium < 125 mmol/L and/or blood potassium < 3.5 mmol/L (Except that blood sodium and/or potassium were restored above this level by sodium and/or potassium supplementation before participating in this study).
  • Patients was known or existing primary or metastatic central nervous system lymphoma, or with any other central nervous system disease (such as seizures, cerebral ischemia/hemorrhage, dementia, etc.).
  • According to the heart function classification standard of New York Heart Association (NYHA), those with grade III or IV cardiac insufficiency; Cardiac ejection fraction is lower than 50% or lower than the lower limit of the laboratory test value range of the research center, or ECG is significantly abnormal.
  • Patients with severe respiratory diseases at the time of enrollment (before apheresis), such as interstitial lung disease, active tuberculosis, etc., investigator considered unsuitable for enrollment.
  • According to the judgment of the investigator, patients with any serious or uncontrollable systemic disease, systemic complications, other serious concurrent diseases (such as hematophilic syndrome, etc.), special tumor conditions may unsuitable for entering this study or affect Protocol compliance, or significant interference with the correct evaluation of the safety, toxicity, and effectiveness of the study drug.
  • Major surgery has been performed within 4 weeks before apheresis (the definition of major surgery refers to the level 3 and level 4 surgery specified in the "Administrative Measures for the Clinical Application of Medical Technology");Or has not fully recovered from any previous invasive operation.
  • Patients received systemic chemotherapy within 3 weeks before apheresis, or the toxicity of previous anti-tumor therapy has not recovered ( > CTCAE v5.0 grade 1), except for hair loss and pigmentation.
  • Patients received Anti-CD30 and other anti-tumor antibody treatments within 4 weeks before apheresis.
  • Patients received any previous systemic inhibitory/stimulatory immune checkpoint molecular therapy (anti-PD-1/PD-L1 monoclonal antibody), and within 3 half-lives.
  • Patients have used immunostimulatory or immunosuppressive therapy (such as IFN-α, IFN-β, IL-2, etanercept, infliximab, tacrolimus, cyclosporine or mycophenolic acid) within 28 days before apheresis.
  • Patients received short-acting targeted therapy (such as tyrosine kinase inhibitors) before apheresis and within 72 hours before infusion.
  • Those who plan to undergo allogeneic/autologous hematopoietic stem cell transplantation during the study period after the investigators assessment.
  • Those who have participated in other interventional clinical study before apheresis or within 1 month before administration.
  • Women who are already pregnant, preparing for pregnant during the study, or breastfeeding.
  • During the study period, women of childbearing age and men with fertility were unwilling or unable to use reliable contraceptive methods.
  • Personnel involved in the research plan and implementation.

Trial locations and contacts

1 site in 1 country.

Huang He, PhD contact

86-13605714822

hehuangyu@126.com

Yongxian Hu, PhD contact

86-15957162012

huyongxian2000@aliyun.com

China1 site

  • The First Affiliated Hospital, College of medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Huang He, PhD, 86-13605714822, hehuangyu@126.com

    Yongxian Hu, 86-15957162012, huyongxian2000@aliyun.com

Other trials in China

About this study

Official title: An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells Injection (Anti CD30 CAR T Cells) in Patients With CD30+ Relapsed/Refractory Lymphoma

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

Read the detailed description

This study is a single-center, open-label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

This study intends to include CD30-positive patients with relapsed/refractory CD30+ lymphoma, and subjects will receive a single injection of anti CD30 CAR-T cells after screening, Peripheral Blood Mononuclear Cell (PBMC) collection, and lymphodepletion chemotherapy pretreatment. Response assessments for lymphoma subjects will base on 2018 Lugano Classification.

Being tested
Anti CD30 CAR-T Cell Injection
Medical subject headings
Hodgkin Disease, Lymphoma, Extranodal NK-T-Cell, Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Anti CD30 CAR-T Cell InjectionBiological

    After enrollment, subjects complete the apheresis, then complete the lymphodepletion, and then receive the dose escalation test: 1.5×10^7 cells，1.5×10^8 cells，5× 10^8 cells.

    Drug: Fludarabine

    Fludarabine is used for lymphodepletion.

    Drug: Cyclophosphamide

    Cyclophosphamide is used for lymphodepletion

Study groups in NCT05208853
Study groupRoleWhat they receive
Anti CD30 CAR T cellsExperimentalPatients receive anti CD30 CAR-T cells on day 0 after lymphodepleting treatment. Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to anti CD30 CAR-T cells infusion.
Receives: Biological: Anti CD30 CAR-T Cell Injection

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    Maximum Tolerated Dose

    Measured: within 4 weeks after infusion

  2. AE and SAE

    To evaluate safety of the cell therapy. Adverse event and serious adverse event.

    Measured: day 0 to month 12

Secondary outcomes (5)

  1. Objective Response Rate, ORR

    Proportion of subjects with complete or partial remission

    Measured: day 0 to month 12

  2. Disease control rate, DCR

    The percentage of patients with remission and stable disease after treatment in the total evaluable cases.

    Measured: day 0 to month 12

  3. Duration of remission, DOR

    The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;

    Measured: day 0 to month 12

  4. Progression-free survival, PFS

    The time from cell reinfusion to the first assessment of tumor progression or death from any cause

    Measured: day 0 to month 12

  5. Overall survival, OS

    The time from the cell reinfusion to death due to any cause.

    Measured: day 0 to month 12

Timeline

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

  1. First posted26 Jan 2022
  2. Study start10 Feb 2022 (estimated)
  3. Primary completion10 Feb 2022 (estimated)
  4. Study completion10 Feb 2022 (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
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208853
Sponsor's protocol ID
ARM002-CN-2021-01
Status last verified
Jan 2022
First submitted
24 Dec 2021
Last updated
26 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Anti CD30 CAR-T Cell Injection in people with Hodgkin Lymphoma and NK/T Cell Lymphoma, run by Zhejiang University 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 21 inclusion and 24 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 26 Jan 2022. 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 Huang He, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: within 4 weeks after infusion). The study lists 2 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 NCT05208853.

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 26 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in