CD30 CAR-T Cells for Low Risk Relapsed Classical Hodgkin Lymphoma

ConditionClassical Hodgkin Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age6-29

SponsorNew York Medical College

About this trial

Patients with relapsed low-risk CD30 classical Hodgkin Lymphoma will have autologous CD30 CAR T-cell manufactured. Dose escalation will be used to determine the RP2D. Following lymphodepletion, CAR T-cell will be infused.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.

Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry.

12 months from end of therapy OR 3-12 months from end of therapy with ≤3 cycles of treatment and no radiation NO B symptoms NO extra nodal disease at relapse NO relapse in a prior radiation field Stage at Diagnosis = IB, IIB, IIIA

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

CD30+ CAR T-cells
Biological/Vaccine
patients with cHL with a good response following reinduction therapy will receive autologous CD30 CAR T-cells 1-14 days following lymphodepletion
Bendamustin
Drug
Patients will receive 70 mg/m2/day × 3 days prior to CD30 CAR T-cells
Fludarabine
Drug
Patients will received 30 mg/m2/day × 3 days prior to CD30 CAR T-cells.

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: CD30+ CAR T-cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

To determine the RP2D of CD30 CAR T-cells

dose escalation will occur for the CD30 CAR T-cells to determine optimal dose with no DLTs.

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Medical College

Lead sponsor

University of North Carolina

Collaborator

Memorial Sloan Kettering Cancer Center