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

Официальное название

REACH-CD30: Reinduction Therapy Followed by Engineered Autologous CD30.CAR T Cells in Children, Adolescents and Young Adults With Lower-Risk CD30+ Relapsed Classical Hodgkin Lymphoma NYMC 628

Обзор

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.

Подробное описание

Patients will have autologous cell collected and they will be manufactured for CD30 CAR T-cells. Following reinduction therapy for relapsed cHL, patients with a good response will receive lymphodepletion therapy and infusion of the CAR T-cells 1-14 days after. We incorporated a dose escalation plan to determine the RP2D. There will be a dose-expansion cohort to collect further safety and manufacturing data.

Вмешательства

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

Первичные конечные точки

• To determine the RP2D of CD30 CAR T-cells [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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:

Stage at Diagnosis = IA, IIA

• 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
• 12 months from end of therapy NO B symptoms NO extranodal disease at relapse NO relapse in a prior radiation field
• 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.
• Planned to undergo reinduction therapy and found to have a favorable response to one line of reinduction therapy. Patients who are refractory to initial reinduction attempts are considered high-risk and thus not eligible for Cell Product Administration and will be removed from study.

Exclusion:

• High-risk relapsed classical Hodgkin Lymphoma with any of the following:

B symptoms extra nodal disease at relapse relapse in a prior radiation field

• Patients under 6 years and over 29 years of age.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07575893 · NYMC 628

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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