CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma

Launched by NEW YORK MEDICAL COLLEGE · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for young patients with a type of cancer called classical Hodgkin Lymphoma (cHL) who are considered to be at high risk. The trial will first treat participants with strong chemotherapy followed by a procedure called autologous stem cell transplantation (AutoHSCT), where their own stem cells are used to help recover their immune system. After this, they will receive a special type of immune therapy called CD30 CAR T-cells, which are designed to specifically target and attack the cancer cells.

To be eligible for this trial, participants should be between 6 and 29 years old and have been diagnosed with CD30+ classical Hodgkin Lymphoma. They must also have had treatment that didn’t work or have experienced a return of their cancer. Additionally, they need to meet certain criteria related to their health and cancer characteristics. If chosen to participate, patients can expect to receive close monitoring and support throughout the treatment process. This trial is currently not recruiting participants, but it represents an important step in exploring new options for treating challenging cases of Hodgkin Lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between ≥ 6 and ≤ 29.99 years at the time of consent.
• • Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
• * Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:
• • Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)
• • Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.
• * Risk Factors: Patient must meet 2 or more of the established risk factors:
• • Performance score (Karnofsky/Lansky) \<;90% Time from diagnosis to first relapse of \<1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, \>60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction
• Exclusion Criteria:
• • not meeting the inclusion criteria