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)
New York Medical College
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.
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…
Eligibility
- Age range
- 6–29 years
- Sex
- All
- 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 rela…
Interventions
- BiologicalCD30 CAR T-cell
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.
Location
- New York Medical CollegeValhalla, New York