CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CD30 CAR T-cell.
- Who it may be relevant to
- Registry conditions: Classical Hodgkin Lymphoma. Basic parameters: 6 years — 29 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
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.
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.
Interventions
- Biological CD30 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.
Primary outcome measures
- Safety of administering CAR T-cells [Time frame: 2 years]
- Feasibility of Central Manufacturing of CAR T-cells [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- New York Medical College — Valhalla
Identifiers
NCT: NCT06617286 · NYMC 624