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

ConditionClassical Hodgkin Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-29

SponsorNew York Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between ≥ 6 and ≤ 29.99 years at the time of consent.

Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)

Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.

Disqualifiers

not meeting the inclusion criteria

Trial design

Design model

Single group

Treatments tested in this trial

CD30 CAR T-cell
Biological/Vaccine
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.

Treatment groups

21 Participants

are divided into 1 treatment group

Group A: CD30 CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

1 year

Sponsors and contacts

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New York Medical College

Lead sponsor

University of North Carolina

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: