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

Phase 2Not Yet RecruitingNCT06617286

New York Medical College21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Classical Hodgkin Lymphoma

Interventions

CD30 CAR T-cellBIOLOGICAL

After MAC and AutoHSCT patients will receive CD30+ CAR T-cells (Phase 1B dose level 1 - 1x108/m2 (max 2.5x108) or dose level 2 - 2x108/m2 (max 5.0 x108) 21-42 days after the AutoHSCT and the RP2D dose level obtained in the Phase IB part administered in the Phase II portion.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 29 Years

Medical Language ↔ Plain English

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

Locations (1)

New York Medical College

Valhalla, New York, United States

Outcomes

Primary Outcomes

Safety of administering CAR T-cells

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.

Time frame: 2 years

Feasibility of Central Manufacturing of CAR T-cells

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.

Time frame: 1 year

Central Contacts

Mitchell S Cairo, MD

CONTACT

914-594-2150 mitchell_cairo@nymc.edu

Lauren Harrison, MSN

CONTACT

617-285-7844 lauren_harrison@nymc.edu

Data from ClinicalTrials.gov

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