A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL) (NCT06287528) | Clinical Trial Compass
RecruitingPhase 1
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
United States18 participantsStarted 2024-02-23
Plain-language summary
Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.
Who can participate
Age range17 Years
SexALL
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Inclusion Criteria:
* Patients must have R/R ALL meeting one of the following criteria:
* For Philadelphia chromosome (Ph) negative B-ALL: Refractory or relapsed disease to at least 1 prior multiagent systemic chemotherapy regimen that included both induction and consolidation therapy
* For Philadelphia chromosome (Ph) positive B-ALL: patients must have exhibited persistent or progressive disease following at least 1 prior second- or third-generation tyrosine kinase inhibitor
* Signed informed consent form (ICF) prior to any study procedures
* Age: The first 3 patients enrolled into the study will be ≥ 17 years of age at time of enrollment. If a DLT is observed, the additional 3 patients in this cohort will also be ≥ 17 years of age. Additional patients will be ≥12 years of age at time of enrollment.
* Documentation of CD19 positivity on leukemia blasts if prior anti-CD19 treatment
* History of prior allogeneic hematopoietic stem cell transplant (HSCT) is allowed if ≥3 months from time of enrollment and no evidence of acute or chronic graft versus host disease (GVHD) within 4 weeks prior to enrollment
* Donor lymphocyte infusions (DLI) permitted if ≥4 weeks prior to leukapheresis
* History of secondary CNS or meningeal involvement allowed if:
* cannot be the only site of disease
* absence of neurologic symptoms, such as: seizures, stroke-like deficits, altered mental status, aphasia, or psychosis
* Adequate organ function at time of screening, including:
* ALT or AST…