CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, B-Cell
• Intervention / Treatment: Drug: chimeric antigen receptor gene modified T cells

Detailed Description

The goal of this clinical trial is to explore the effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:

To evaluate the safety of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jia wei; Phone Number: 13986102084; Email: iawei@tjh.tjmu.edu.cn

Study Locations

• China
  • Shangxi
    • Taiyuan, Shangxi, China
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: jia wei; Phone Number: 13986102084; Email: jiawei@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age≥15 years and ≤80years，female and male；
• CD30+ lymphocyte malignancies;
• CD30 expression >10% by immunohistochemistry；
• At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
• Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
• Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
• The estimated survival time ≥3 months;
• ECOG performance status 0-2，KPS>60%;
• Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin<34 μmol/L；creatinine clearance rate>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；
• ALC ≥0.5×109/L，PLT>30×109/L，Hb>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation;
• MRI showed no central involvement of lymphoma;
• Patients with fertility must be willing to be able to use reliable contraceptive measures ;
• The subject or legal guardian can understand and voluntarily sign the written informed consent.

Exclusion Criteria:

• Lymphoma-associated hemophagic cell syndrome;
• Pregnant or lactating women, and women who have a pregnancy plan within six months;
• Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ/Ⅱ and anti-TP positive（Hepatitis B DNA test is negative except）;
• Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;
• Received Anti-CD30 Ab therapy within 4 weeks before enrollment;
• Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments;
• Active uncontrolled bleeding or a known bleeding diathesis;
• Autologous hematopoietic stem cell transplantation was performed within 6 weeks;
• Uncontrollable active bacterial or fungal infection；
• Known allergy to the study drug and its components;
• Suffer from active autoimmune diseases that require systemic treatment ;
• Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
• Participated in other clinical studies within 1 months prior to this study;
• History of allogeneic hematopoietic stem cell transplantation;
• patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1; Subjects received a single low-dose CD30 CAR-T therapy(1*10^6/kg CAR+T cells)	Drug: chimeric antigen receptor gene modified T cells; The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline.; Other Names: CAR-T
Experimental: Group2; Subjects received a single low-dose CD30 CAR-T therapy(2*10^6/kg CAR+T cells)	Drug: chimeric antigen receptor gene modified T cells; The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline.; Other Names: CAR-T
Experimental: Group3; Subjects received a single low-dose CD30 CAR-T therapy(5*10^6/kg CAR+T cells)	Drug: chimeric antigen receptor gene modified T cells; The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline.; Other Names: CAR-T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Including complete remission (CR) and partial remission (PR)	6 months
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose	Incidence of DLTs and occurrence of study related adverse events	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS was calculated from the first CAR-T cell infusion to death or last follow-up	3 years
Disease-free survival	DFS 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.	3years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The copy number of CD30 CAR-T cells	The copy number of CD30 CAR-T cells amplified in peripheral blood after administration	12 months

Collaborators and Investigators

• Sponsor: Shanxi Bethune Hospital
• Investigators: Principal Investigator: jia wei, Shanxi Bethune Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CD30 CAR-T; lymphoma
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: ICT-CD30-2311-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No