Clinical trial · Interventional
CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
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)
NCT06617286CI-TRIAL-00108316not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD30 CAR T-cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD30 CAR T-cells
- description
- Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.
- interventionNames
- Biological: CD30 CAR T-cell
Primary outcomes (2)
- measure
- Safety of administering CAR T-cells
- timeFrame
- 2 years
- description
- 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.
- measure
- Feasibility of Central Manufacturing of CAR T-cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 29 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.