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NOT YET RECRUITING
NCT07729397
PHASE1

Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas. Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs. The primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2027-01-15

Completion Date

2044-02-28

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous C7R.CD30-CAR-EBVSTs

Autologous Epstein-Barr virus-specific T lymphocytes genetically modified to express a constitutively active interleukin-7 receptor (C7R), a CD30-specific chimeric antigen receptor (CAR), and an inducible caspase 9 (iC9) safety switch. The investigational product is manufactured from autologous peripheral blood mononuclear cells and administered by intravenous infusion following lymphodepleting chemotherapy.

Locations (1)

Houston Methodist Hospital

Houston, Texas, United States