CD30 CAR-T in the Treatment of CD30 Positive Lymphoma

NCT07048353 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ICT-C30-235-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The is a prospective, open-label, dose-climbing multicenter 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。

Conditions

Lymphoma; B Cell Lymphoma; CD30+ Peripheral T-cell Lymphoma

Keywords

CD30 CAR-T; lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall response rate

  3,6,12months

• Overall Survival

  3 years

• Progression-free survival

  3 years

Other Outcomes (1)

• The copy number of CD30 CAR-T cells

  12 months

Study Arms (3)

Group1

EXPERIMENTAL

Subjects received a single low-dose CD30 CAR-T therapy

Drug: chimeric antigen receptor gene modified T cells

Group2

EXPERIMENTAL

Subjects received a single medium-dose CD30 CAR-T therapy

Drug: chimeric antigen receptor gene modified T cells

Group3

EXPERIMENTAL

Subjects received a single high-dose CD30 CAR-T therapy

Drug: chimeric antigen receptor gene modified T cells

Interventions

chimeric antigen receptor gene modified T cells DRUG

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.

Group1; Group2; Group3

Eligibility Criteria

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

You may qualify if:

• Age≥18 years and ≤65years，female and male；
• CD30+ recurrent/refractory malignant hematological malignancies, experienced recurrence (disease progression after treatment remission) or refractory (previous systemic treatment did not achieve CR) after ≥ 2-line systemic treatment;
• CD30 expression \>10% by immunohistochemistry；
• At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Qilu Cell Therapy Engineering Technology Co., Ltd: lead
• Tongji Hospital Affiliated to Tongji Medical College of HUST: collaborator
• Shanxi Bethune Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of HUST

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Central Study Contacts

LU Qi

CONTACT

+8619953190982; zhangchunfeng@yinfeng.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): July 28, 2029
• Study Completion (Estimated): July 28, 2029
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)