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Relapsed or Refractory LymphomaPhase 1NCT07453446

Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma

A Phase 1 study testing CD30 CAR-T Cells in people with Relapsed or Refractory Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Relapsed or Refractory Lymphoma
What is being tested?
CD30 CAR-T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
4 Mar 2025to 31 Mar 2029
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

  • Subjects must provide written informed consent and demonstrate good compliance with study procedures.
  • Age between 18 and 70 years, inclusive; male or female.
  • Histologically confirmed relapsed or refractory lymphoma (with priority for Hodgkin lymphoma, anaplastic large cell lymphoma, or other lymphoproliferative disorders), with CD30 expression confirmed by immunohistochemistry or flow cytometry (≥50% positive cells).
  • Relapsed or refractory disease, defined as:
  • Hodgkin Lymphoma (HL):
  • Failure to achieve remission or disease progression after autologous hematopoietic stem cell transplantation (auto-HSCT); OR
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  • Failure of at least two prior lines of systemic chemotherapy; OR
  • Ineligibility for auto-HSCT due to:
  • Chemotherapy resistance (failure to achieve CR or PR after salvage chemotherapy);
  • Failed stem cell collection, or investigator-assessed inability to collect, or severe comorbidities, or patient refusal of auto-SCT.
  • Anaplastic Large Cell Lymphoma (ALCL): Failure of at least two prior lines of systemic chemotherapy or relapse after response.
  • Other CD30+ lymphomas: No standard treatment options available, or failure after standard therapy.
  • At least one evaluable lesion according to the Lugano Classification for Malignant Lymphomas (Cheson 2014).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
  • Adequate bone marrow reserve at screening:
  • Absolute lymphocyte count (ALC) ≥ 0.3 × 10⁹/L;
  • Platelet count (PLT) ≥ 30 × 10⁹/L (transfusion-supported values are acceptable).
  • Adequate organ function, defined as:
  • Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN if due to tumor infiltration);
  • Total serum bilirubin ≤ 2 × ULN, except for Gilbert's syndrome (total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN);
  • Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula);
  • No more than grade 1 dyspnea, and oxygen saturation > 91% on room air;
  • Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiogram;
  • International Normalized Ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to CAR-T infusion. All sexually active males and females of childbearing potential must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.
  • Adequate venous access for leukapheresis or blood collection, and no contraindications to leukapheresis.
  • Expected survival of at least 3 months.

Who cannot join

  • History of another malignancy, except for malignancies in complete remission for > 3 years or carcinoma in situ.
  • Lymphoma infiltration of the cardiac atria or ventricles.
  • Use of immunosuppressive agents or corticosteroids within 1 week prior to leukapheresis, unless the investigator determines that the impact on T cells is minimal.
  • Presence of any of the following:
  • Positive hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification;
  • Positive hepatitis C antibody (HCV-Ab) with HCV-RNA copy number above the lower limit of quantification;
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  • Positive Treponema pallidum antibody (TP-Ab);
  • Positive human immunodeficiency virus (HIV) antibody test.
  • Bacterial, fungal, viral, mycoplasmal, or other type of infection that is judged by the investigator to be difficult to control.
  • Previous or current central nervous system (CNS) disease unrelated to the current lymphoma, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease, unless judged by the investigator to be controllable.
  • Any of the following within 12 months prior to signing informed consent:
  • Cardiac angioplasty or stenting;
  • New York Heart Association (NYHA) Class III-IV congestive heart failure;
  • Myocardial infarction, unstable angina, or other clinically significant cardiac history as judged by the investigator;
  • QTc interval > 480 ms (calculated using the Fridericia formula) at screening;
  • Left ventricular ejection fraction (LVEF) < 50% on echocardiogram.
  • Primary immunodeficiency.
  • History of severe immediate hypersensitivity reaction to any of the study drugs.
  • Administration of a live vaccine within 6 weeks prior to screening.
  • Pregnant or lactating female.
  • Active autoimmune disease.
  • Active acute or chronic graft-versus-host disease (GVHD) at the time of signing informed consent.
  • Allogeneic hematopoietic stem cell transplantation within 6 months prior to signing informed consent.
  • Participation in any other interventional clinical trial within 30 days prior to signing informed consent.
  • Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hebei Yanda Lu Daopei Hospital

    Sanhe

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CD30-targeted Chimeric Antigen Receptor T (CAR-T) Cell Injection in Patients With CD30-positive Relapsed or Refractory Lymphoma

This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma.

Read the detailed description

The primary purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of CD30-targeted CAR-T cell therapy in participants with CD30-positive relapsed or refractory lymphoma.

Being tested
CD30 CAR-T Cells
Keywords
CD30, CD30-CART
Medical subject headings
Recurrence, Lymphoma

What participants receive

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

  • CD30 CAR-T CellsDrug

    Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.

Study groups in NCT07453446
Study groupRoleWhat they receive
U29(CD30 CAR-T Cells)ExperimentalNot described
Receives: Drug: CD30 CAR-T Cells

What is being measured

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

  1. Incidence of Dose-Limiting Toxicity (DLT) and Treatment-Emergent Adverse Events (TEAEs) Within 28 Days Post CAR-T Infusion

    Incidence, type, frequency, and severity of DLT within 28 days post CAR-T infusion; incidence of TEAEs, clinically significant abnormalities in laboratory tests, vital signs, electrocardiogram (ECG), and echocardiography results after CAR-T infusion, graded by CTCAE v5.0.

    Measured: 28 days post CAR-T cell infusion (for DLT); up to 24 months post CAR-T cell infusion (for other safety assessments)

  2. Objective Response Rate (ORR), as assessed by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission(PR)

    Measured: 2 years post CAR T cell infusion

  3. Duration of response (DOR)

    Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.

    Measured: 2 years post CAR T cell infusion

  4. Overall survival (OS)

    Overall Survival (OS) was defined as the time from the date of first infusion of U01 to the date of death due to any cause.

    Measured: 2 years post CAR T cell infusion

  5. Progression-free survival (PFS)

    Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: 2 years post CAR T cell infusion

Secondary outcomes (4)

  1. Pharmacokinetics of U29

    Time at the maximal concentration(Tmax)

    Measured: 2 years post CAR T cell infusion

  2. Pharmacokinetics of U29

    Area under the concentration-time curve(AUC)

    Measured: 2 years post CAR T cell infusion

  3. Pharmacokinetics of U29

    The maximal concentration of peripheral blood (Cmax)

    Measured: 2 years post CAR T cell infusion

  4. Pharmacodynamics of U29

    Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point

    Measured: 2 years post CAR T cell 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 Mar 2026
  2. Study start4 Mar 2025 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Why it stopped: The main consideration is the allocation of company resources, We can only terminate this research.

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453446
Sponsor's protocol ID
U29
Status last verified
Mar 2026
First submitted
1 Mar 2026
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD30 CAR-T Cells in people with Relapsed or Refractory Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd 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 28 inclusion and 25 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: withdrawn, as of the sponsor's last update on 6 May 2026. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicity (DLT) and Treatment-Emergent Adverse Events (TEAEs) Within 28 Days Post CAR-T Infusion (time frame: 28 days post CAR-T cell infusion (for DLT); up to 24 months post CAR-T cell infusion (for other safety assessments)). The study lists 5 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 NCT07453446.

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 May 2026.

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