Not Yet RecruitingPhase 1

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

12 participantsStarted 2026-12-01

Plain-language summary

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.

Who can participate

Age range6 Years – 29 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Risk Factors: Patient must meet established low-risk factors:
✓. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label.
✓. Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the cell infusion therapy.
✓. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
✓. Subject is willing and able to comply with study procedures based on the judgement of the investigator.

Exclusion criteria

✕. High-risk relapsed classical Hodgkin Lymphoma with any of the following:
✕. Patients under 6 years and over 29 years of age.

What they're measuring

To determine the RP2D of CD30 CAR T-cells

Timeframe: 1 year

Trial details

NCT IDNCT07575893

SponsorNew York Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-12-01

Contact for this trial

Mitchell S Cairo, MD

914-594-2150 mcairo@nymc.edu

View on ClinicalTrials.gov More Classical Hodgkin Lymphoma trials