Actively Recruiting
Phase 1
Age: 18Years +
All Genders
NCT06066424
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
54
Participants Needed
1
Research Sites
861 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Bellicum Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find the recommended dose of TROP2- CAR-NK cells that can be given to participants with advanced forms of solid tumors.
CONDITIONS
Official Title
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Able and willing to provide informed consent.
- Have histologically confirmed locally advanced, unresectable, or metastatic solid tumor that has relapsed or progressed after standard treatments, or no standard treatment is available, or refused such therapy.
- For dose expansion Cohort 1: histologically confirmed locally advanced, unresectable, or metastatic NSCLC with at least two prior lines of therapy in advanced setting; prior immunotherapy expected for PD-L1-positive metastatic disease unless contraindicated; prior FDA-approved targeted therapy for actionable mutations.
- For dose expansion Cohort 2: histologically confirmed locally advanced or metastatic HER2-negative/HER2-low breast cancer; at least one prior line of therapy in advanced setting; prior immunotherapy expected for PD-L1-positive metastatic TNBC unless contraindicated; prior CDK4/6 inhibitor expected for HR-positive disease.
- Tumors must show TROP2 expression of 2+ or 3+ by IHC.
- ECOG performance status 0 or 1.
- Life expectancy of at least 3 months.
- Female participants must be non-childbearing or follow contraceptive guidelines during and for 6 months after treatment.
- Male participants must follow contraceptive guidelines during and for 6 months after treatment.
- Negative pregnancy test for women of childbearing potential within 72 hours prior to lymphodepleting chemotherapy.
- Measurable disease per RECIST v1.1.
- Adequate organ function based on specified laboratory values within 10 days prior to lymphodepleting chemotherapy.
- Left ventricular ejection fraction greater than 50%.
- Adequate respiratory reserve with dyspnea Grade 0 or 1 and oxygen saturation over 92% in room air.
- Prior TROP2-targeted therapy allowed.
- Willing to undergo required blood collections and biopsies.
- Agree to long-term follow-up consent.
- Willing to stay within 2-hour drive of study site during first 2 weeks after infusion.
You will not qualify if you...
- Pregnant, breastfeeding, or planning to conceive during study and up to 6 months after infusion.
- Received systemic anticancer therapy within 2 weeks or 5 half-lives prior to lymphodepleting chemotherapy, or monoclonal antibody therapy less than 3 weeks prior.
- Not recovered from adverse events from prior therapies to Grade 1 or baseline, except certain neuropathies or alopecia.
- Received radiotherapy within 2 weeks prior to lymphodepleting chemotherapy, with exceptions for certain palliative radiation.
- Received live vaccine within 6 weeks prior to infusion or planned during 24 months post-infusion.
- Prior CAR T, NK cell, or other genetically modified T or NK cell therapy.
- Immunodeficiency or chronic systemic steroid therapy over 10 mg prednisone equivalent daily.
- History of second malignancy without 2 years of no evidence of disease, except certain in situ or superficial cancers.
- Active central nervous system metastases or carcinomatous meningitis, unless previously treated and stable.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History of interstitial lung disease requiring steroids or current pneumonitis/ILD.
- Active infection needing systemic therapy.
- Known HIV infection.
- Active or chronic hepatitis B or C infection.
- History of active tuberculosis.
- Any condition or therapy that may interfere with study participation or results.
- Psychiatric or substance abuse disorders interfering with study cooperation.
- History of allogenic tissue or solid organ transplant.
- Significant cardiovascular disease within 12 months prior to lymphodepleting chemotherapy.
- Prolonged QT interval over 480 milliseconds.
- Bleeding or thrombotic disorders or at risk for severe hemorrhage, except those on anticoagulation for deep vein thrombosis or pulmonary embolism.
- History of Grade 3 or higher stomatitis or mucositis with prior therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
E
Ecaterina Dumbrava, M D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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