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Trial Title:
CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
NCT ID:
NCT06617286
Condition:
Classical Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Conditions: Keywords:
classical Hodgkin lymphoma
CAR T-cells
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD30 CAR T-cell
Description:
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.
Arm group label:
CD30 CAR T-cells
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.
Criteria for 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
Gender:
All
Minimum age:
6 Years
Maximum age:
29 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
New York Medical College
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Contact:
Last name:
Mitchell S Cairo, MD
Phone:
914-594-2150
Email:
mitchell_cairo@nymc.edu
Start date:
December 1, 2024
Completion date:
December 31, 2040
Lead sponsor:
Agency:
New York Medical College
Agency class:
Other
Collaborator:
Agency:
University of North Carolina
Agency class:
Other
Source:
New York Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617286
