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

NCT06850285 | Recruiting

• 1 other identifier: ICT-CD30-2311-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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。

Conditions

Lymphoma, B-Cell

Keywords

CD30 CAR-T; lymphoma;

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Disease-free survival

  3years

• Overall 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(1\*10\^6/kg CAR+T cells)

Drug: chimeric antigen receptor gene modified T cells

Group2

EXPERIMENTAL

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

Group3

EXPERIMENTAL

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

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.

Also known as: CAR-T

Group1; Group2; Group3

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shangxi, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• jia wei

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jia wei

CONTACT

13986102084; iawei@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 27, 2025

Record last verified: 2024-03

Locations

CN (1)