Targeting CD30 in Lymphomas with CAR-T Therapy

A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

This study is testing a new CAR-T therapy called ICAR30 to see if it can help people with Hodgkin lymphoma and anaplastic large cell lymphoma that hasn't responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 2 Years to 80 Years
• Sex: All
• Sponsor: Immune Cell, Inc. (industry)
• Drugs / interventions: CAR-T, CART
• Locations: 1 site (Weifang, Shandong)
• Trial ID: NCT03383965 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a novel CAR-T therapy, ICAR30, designed to target and kill CD30-expressing malignancies, specifically Hodgkin lymphoma and anaplastic large cell lymphoma. Participants will receive multiple infusions of autologous ICAR30 T cells, and the study will evaluate the safety, efficacy, and persistence of these cells in the body. The trial aims to provide a new treatment option for patients with relapsed or refractory CD30-positive lymphomas.

Who should consider this trial

Good fit: Ideal candidates include individuals with Hodgkin lymphoma, anaplastic large cell lymphoma, or other CD30-positive malignancies who have relapsed or are refractory to previous treatments.

Not a fit: Patients who are pregnant, have uncontrolled infections, or significant CNS dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new, effective treatment option for patients with difficult-to-treat lymphomas.

How similar studies have performed: While CAR-T therapies have shown success in treating other types of lymphomas, this specific approach targeting CD30 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:

* Karnofsky or Lansky score \>50;
* Expected survival\>12 weeks;
* Hgb \> 8.0;
* FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
* LVEF≥50%;
* Creatinine\<2.5mg/dl;
* Bilirubin\<2.5mg/dl;
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal;
* Patients must sign an informed consent.

Exclusion Criteria:

* Pregnant or lactating;
* Uncontrolled active infection including hepatitis B or C;
* HIV positive;
* Active clinically significant CNS dysfunction;
* Current use of systemic steroids;
* Heterogenous lymphocyte treatments within recent 6 months;

Where this trial is running

Weifang, Shandong

• Weifang People's Hospital — Weifang, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Xiulian Sun, MD.,Ph.D

Conditions: Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma