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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD30 CAR T-cells | Experimental | Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD30 CAR T-cell | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
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Inclusion Criteria:
Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell S Cairo, MD | Contact | 914-594-2150 | mitchell_cairo@nymc.edu | |
| Lauren Harrison, MSN | Contact | 617-285-7844 | lauren_harrison@nymc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell S Cairo, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
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