NK Cells + Chemotherapy for Sarcoma (TINKS Trial)

Phase 1 & 2

Recruiting

Led By Bhuvana Setty, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if adding NK cells to chemo can improve outcomes in kids w/ sarcomas that haven't responded to prior treatments.

Who is the study for?

This trial is for young people aged 12-40 with relapsed or refractory pediatric bone and soft tissue sarcomas, who've had limited prior treatments. They must have a certain level of physical ability, adequate organ function, controlled seizures if present, no severe allergies to specific drugs used in the study, and agree to use contraception.

What is being tested?

The study tests whether adding TGFβ imprinted NK cells (a type of immune cell) to standard chemotherapy (gemcitabine and docetaxel) improves outcomes for these sarcoma patients. The treatment involves multiple cycles of chemo plus NK cell infusions over several weeks.

What are the potential side effects?

Potential side effects include reactions from the infusion of NK cells or chemotherapy such as fatigue, nausea, infection risk increase due to lowered white blood cell counts, possible allergic reactions, and other common chemo-related issues like hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1

Part 2

Secondary study objectives

Frequency and characterization of DLT in study patients

Treatment response of target lesions determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Other study objectives

Exploratory Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Part 1: Enrollment of 5 patients in each cohort (osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and non-rhabdomyosarcoma). Part 2: Enrollment of 2 cohorts in 2 stages for a total of 40 patients.

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