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

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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