CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

1. Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
2. Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo re-induction therapy.
3. Confirmatory re-biopsy of relapsed CD30+ cHL prior to study entry.
4. 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
5. 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.
6. 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.
7. 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.
8. Subject is willing and able to comply with study procedures based on the judgement of the investigator.
9. 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:

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

   B symptoms extra nodal disease at relapse relapse in a prior radiation field
2. Patients under 6 years and over 29 years of age.

主要终点：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. · 1 year

• CD30+ CAR T-cells · EXPERIMENTAL · Patients will receive infusion of autologous CD30+ CAR T-cells previously manufactured following lymphoma depletion with bendamustine and fludarabine. Dose will vary until RP2D determined.

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.