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

NCT07453446 | Withdrawn Phase 1

• 1 other identifier: U29
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory Lymphoma

Keywords

CD30; CD30-CART

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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)

  2 years post CAR T cell infusion

• 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.

  2 years post CAR T cell infusion

• 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.

  2 years post CAR T cell infusion

• 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.

  2 years post CAR T cell infusion

Secondary Outcomes (4)

• Pharmacokinetics of U29

  2 years post CAR T cell infusion

• Pharmacokinetics of U29

  2 years post CAR T cell infusion

• Pharmacokinetics of U29

  2 years post CAR T cell infusion

• Pharmacodynamics of U29

  2 years post CAR T cell infusion

Study Arms (1)

U29(CD30 CAR-T Cells)

EXPERIMENTAL

Drug: CD30 CAR-T Cells

Interventions

CD30 CAR-T Cells DRUG

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.

U29(CD30 CAR-T Cells)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: lead

Study Sites (1)

Hebei Yanda Lu Daopei Hospital

Sanhe, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: March 4, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-03

Locations

CN (1)