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

New York Medical College

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Classical Hodgkin Lymphoma

Treatments: Biological: CD30 CAR T-cell

Study type: Interventional

Funder types: Other

Identifiers

NCT06617286

NYMC 624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 6 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

CD30 CAR T-cells

Experimental group

Description:

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

Treatment:

Biological: CD30 CAR T-cell