Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Lo… (NCT06069570) | Clinical Trial Compass
RecruitingPhase 1
Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Locally Advanced or Metastatic NSCLC or Solid Tumors With Bone Metastases
United States48 participantsStarted 2023-11-07
Plain-language summary
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed and dated informed consent form.
* Male or female, \> 18 years old.
* Minimum body weight of 50 kilograms (kg).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis
* Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy.
* Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.
* At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease
* All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.
* Adequate hematopoietic, hepatic and renal function
* Agree to adequate contraception for up to 120 days after the last dose of study drug.
* Negative serum pregnancy test for women of childbearing potential
* All primary and metastatic disease sites are amenable to LDRT
* For solid tumors with bone …
What they're measuring
1
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
Timeframe: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later