NCT05989204 TmCD19-IL18 in CD19+ Cancers

Trial Parameters

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Brief Summary

This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.

Eligibility Criteria

1. Signed informed consent form 2. Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory. a. Cohort A (NHL): Within 6 months of physician-investigator confirmation of eligibility as long as there has been no intervening CD19 directed therapy since expression confirmed. Results outside of this window may be used, if there is no accessible tumor site and the subject did not receive intervening CD19 directed therapy since CD19 expression was confirmed. 3. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria: 1. Have no active GVHD and require no immunosuppression 2. Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility 4. Adequate organ function defined as: 1. Estimated creatinine clearance \> 35 mL/min and not on dialysis 2. ALT/AST ≤ 3x upper limit of normal range 3. Direct bilirubin ≤ 2.0 mg/dl, unless the subject has Gilbert's syndrome (≤3.0 mg/

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