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OncoMatch/Clinical Trials/NCT05989204

TmCD19-IL18 in CD19+ Cancers

Is NCT05989204 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TmCD19-IL18 for non hodgkin lymphoma.

Phase 1RecruitingUniversity of PennsylvaniaNCT05989204Data as of May 2026

Treatment: TmCD19-IL18This 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.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD19 expression (positive)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: CAR T cell therapy — relapsed/refractory or ineligible

Patients must have either relapsed after, or be ineligible for, prior CAR T cell therapy

Cannot have received: huCART19-IL18 therapy

Receipt of prior huCART19-IL18 therapy

Lab requirements

Kidney function

Estimated creatinine clearance > 35 mL/min and not on dialysis

Liver function

ALT/AST  3x upper limit of normal range; Direct bilirubin  2.0 mg/dl, unless the subject has Gilbert's syndrome ( 3.0 mg/dl)

Cardiac function

Left Ventricle Ejection Fraction (LVEF)  40% confirmed by ECHO

Adequate organ function defined as: Estimated creatinine clearance > 35 mL/min and not on dialysis; ALT/AST  3x upper limit of normal range; Direct bilirubin  2.0 mg/dl, unless the subject has Gilbert's syndrome ( 3.0 mg/dl); Must have a minimum level of pulmonary reserve defined as  Grade 1 dyspnea and pulse oxygen > 92% on room air; Left Ventricle Ejection Fraction (LVEF)  40% confirmed by ECHO

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Pennsylvania · Philadelphia, Pennsylvania

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