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

Phase 1

Not yet recruiting

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Biological: CD30 CAR T-cell

• Registration Number: NCT06617286
• Lead Sponsor: New York Medical College

Brief Summary

Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.

Detailed Description

Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected (PBSC) and stored for future AutoHSCT.

After another screening for MAC+AutoHSCT, patients who meet criteria will receive BEAM conditioning followed by AutoHSCT. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30+ CAR T-cell infusion, if they meet subsequent pre CD30+ CAR T-cell eligibility criteria.

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-18
• Study Start: 2024-12-01
• Primary Completion: 2039-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD30 CAR T-cells	CD30 CAR T-cell	Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.

Primary Outcome Measures

Name	Time	Method
Safety of administering CAR T-cells	2 years	To evaluate the incidence of adverse events related to autologous CD30+ CAR T-cell infusions including not limited to infusions related reactions (IRR) (CTCAE 5.0), cytokine release syndrome (CRS) (ASCTC), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (ASCTC) and all general grade 3-5 toxicities (CTCAE 5.0) in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.
Feasibility of Central Manufacturing of CAR T-cells	1 year	To evaluate the feasibility of local site PBMC collection and central GMP CD30 CAR T cell manufacturing with a 75% success rate in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT.

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States