MAC-CAR: A Phase 1B/II Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30+ CAR T Cells in Children, Adolescents and Young Adults With Poor-Risk Classical Hodgkin Lymphoma (cHL)
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- New York Medical College
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Safety of administering CAR T-cells
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 29 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CD30 CAR T-cells
Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.
Intervention: CD30 CAR T-cell (Biological)
Outcomes
Primary Outcomes
Safety of administering CAR T-cells
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported