Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05681780
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Tumor-infiltrating Lymphocytes (TIL) — BIOLOGICAL
    Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
  • Nivolumab — DRUG
    Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered on days -7 and -6.
  • Fludarabine — DRUG
    Fludarabine will then be infused per institutional standard on Days -7 to -3.
  • Tumor-infiltrating Lymphocyte Therapy — OTHER
    On day 0, all patients will receive a dose infusion TIL cells.
  • Interleukin-2 (IL2) — DRUG
    Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.

Study Details

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Key Dates

Start date
Mar 10, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TIL+ Nivolumab
    Nivolumab infusion every 3 weeks prior to lymphodepletion chemotherapy with cyclophosphamide/fludarabine, TIL infusion and interleukin-2. Then nivolumab infusion every 4 weeks up to 12 months.

Primary Outcome Measure

Adverse Events (AE) [ Time Frame: Up to 18 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Tanner Pearson
[email protected]
813-745-6552
Ben Creelan, MD, MS (PRINCIPAL_INVESTIGATOR)
Daniel Abate Daga, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Moffitt Cancer Center· Tampa, FL

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