CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma

NCT06617286 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NYMC 624
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Classical Hodgkin Lymphoma

Keywords

classical Hodgkin lymphoma; CAR T-cells

Outcome Measures

Primary Outcomes (2)

• Safety of administering CAR T-cells

  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.

  2 years

• Feasibility of Central Manufacturing of CAR T-cells

  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.

  1 year

Study Arms (1)

CD30 CAR T-cells

EXPERIMENTAL

Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.

Biological: CD30 CAR T-cell

Interventions

CD30 CAR T-cell BIOLOGICAL

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.

CD30 CAR T-cells

Eligibility Criteria

• Age: 6 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead
• University of North Carolina: collaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

Study Officials

• Mitchell S Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell S Cairo, MD

CONTACT

914-594-2150; mitchell_cairo@nymc.edu

Lauren Harrison, MSN

CONTACT

617-285-7844; lauren_harrison@nymc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 27, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2039
• Study Completion (Estimated): December 31, 2040
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)