TmCD19-IL18 in CD19+ Cancers

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05989204
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TmCD19-IL18 — BIOLOGICAL
    autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)

Study Details

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.

Key Dates

Start date
Nov 13, 2023
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2041

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NHL Dose Level 1
    7x10\^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
  • Experimental: NHL Dose Level -1
    2x10\^6 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
  • Experimental: NHL Dose Level 2
    2x10\^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
  • Experimental: NHL Dose Level 3
    6x10\^7 TmCD19-IL18 cells administered as a single intravenous (IV) infusion
  • Experimental: NHL Dose Level 1a
    5x10\^6 TmCD19-IL18 CAR T cells

Primary Outcome Measure

Number of subjects with dose limiting toxicities (DLTs) [ Time Frame: 28 days after TmCD19-IL18 CART T cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Abramson Cancer Center Clinical Trial Services
[email protected]
215-349-8245

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By research site
University of Pennsylvania· Philadelphia, PA

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