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Not yet recruiting NCT07048353

CD30 CAR-T in the Treatment of CD30 Positive Lymphoma

Early Phase I Interventional Lymphoma B Cell Lymphoma CD30+ Peripheral T-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: chimeric antigen receptor gene modified T cells.
Who it may be relevant to
Registry conditions: Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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。

Detailed description

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

To evaluate the safety and maximum tolerated dose 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.

Interventions

  • 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.

Primary outcome measures

  • To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose [Time frame: 28 days]
Secondary outcome measures (3)
  • Overall response rate [Time frame: 3,6,12months]
  • Overall Survival [Time frame: 3 years]
  • Progression-free survival [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital Affiliated to Tongji Medical College of HUST — Wuhan

Identifiers

NCT: NCT07048353 · ICT-C30-235-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗