huCART19-IL18-eDHFR Cells in Relapsed/Refractory Follicular Lymphoma

Conditions

• Relapsed or Refractory Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• huCART19-IL18-eDHFR cells — BIOLOGICAL
  Genetically modified autologous T cells engineered by co-transduction with two lentiviral vectors; one vector expressing a chimeric antigen receptor (CAR) targeting the CD19 antigen and human Interleukin 18 (IL-18), and a second vector expressing E.coli dihydrofolate reductase (eDHFR)
• [18F]Fluoropropyl-Trimethoprim — DRUG
  Co-expression of eDHFR within huCART19-IL18 cells will allow the trafficking of the transduced CAR T cells to be visualized by PET/CT imaging using an investigational radiolabeled imaging agent \[18F\]Fluoropropyl-Trimethoprim (also known as \[18F\]FP-TMP).

Study Details

This is a phase 1, open-label study to evaluate the feasibility, safety and preliminary efficacy of huCART19-IL18-eDHFR cells administered in patients with relapsed or refractory follicular lymphoma. This study will be initiated as a single arm study (Treatment Arm A), which will evaluate the use of huCART19-IL18-eDHFR cells without prior lymphodepletion. In this Treatment Arm A, all subjects will receive a single flat dose of 7x10\[6\] huCART19-IL18-eDHFR cells (Dose Level 1; DL1). Additional treatment arms may also be introduced in the future, via subsequent amendment(s). Co-expression of eDHFR within huCART19-IL18 cells will allow the trafficking of the transduced CAR T cells to be visualized by PET/CT imaging using an investigational radiolabeled imaging agent \[18F\]Fluoropropyl-Trimethoprim (also known as \[18F\]FP-TMP). The feasibility of using \[18F\]FP-TMP PET/CT imaging to detect and measure the eDHFR-expressing CAR T cells will be investigated, as well as its ability to provide insight into CAR T cell pharmacokinetics, biodistribution, and persistence.

Key Dates

First listed

Jan 15, 2026

Start date

May 18, 2026

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2042

Study Design

Enrollment

6 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A - DL1
  IV administration of a single flat dose of 7x10\[6\] huCART19-IL18-eDHFR cells. \[18F\]FP-TMP PET/CT scan.
• Experimental: Arm A - DL-1
  IV administration of a single flat dose of 3x10\[6\] huCART19-IL18-eDHFR cells. \[18F\]FP-TMP PET/CT scan.

Primary Outcome Measure

Change in Tumor Uptake on [18F]FP-TMP PET/CT [ Time Frame: Up to 6 months after huCART19-IL18-eDHFR administration ]

Central Contacts

• Abramson Cancer Center Clinical Trials Service
  215-349-8245
  [email protected]
• Stephen Schuster, MD

Locations (1)

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