Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT05138458
Eligibility Criteria:
Key Inclusion Criteria:
* Adults age \> or equal to18 at the time the Informed Consent is signed
* Refractory or relapsed pathologically confirmed T Cell Lymphoma (TCL): Peripheral T cell Lymphoma not otherwise specified (PTCL-NOS) , Angioimmunoblastic T cell Lymphoma (AITL), ALK-negative anaplastic large cell lymphoma (ALCL), ALK-positive ALCL, or Mycosis Fungoides (MF) stage IIB-IV including large cell transformation
* CD5-expressing tumor by IHC or flow cytometry of tumor biopsy within 3 months of Screening or at Screening
* Eastern Cooperative Oncology Group performance status \< 2
* Adequate organ function as defined in the protocol.
Key Exclusion Criteria:
* B1 and B2 disease (as defined in protocol for subjects with MF)
* Known central nervous system involvement by PTCL
* History of allogeneic transplant
* History of intolerance to leukapheresis, plasmapheresis, or blood donation
* Pregnant or nursing women
* Any acute illness including fever (\> 100.4°F or \> 38°C), except fever related to tumor
* Active systemic bacterial, fungal, or viral infection
* Active chronic infection
* Other primary malignancies, except adequately treated malignancies or complete remission
* Active autoimmune disease that has required systemic therapy in the last 2 years
* History of hemophagocytic lymphohistiocytosis
* History of severe, immediate hypersensitivity reaction attributed to penicillin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05138458
Study Brief:
Protocol Section:
NCT05138458