← Back to Search

CAR T-cell Therapy

TROP2-CAR-NK Cells for Solid Cancers

Phase 1

Recruiting

Led By Ecaterina Dumbrava, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy: Table 1. Adequate Organ Function Laboratory Values Systemic Function Test Laboratory Value Hematologic ANC ≥1500/µL Platelets ≥100,000/µL Hemoglobin ≥9.0 g/dLa Renal Creatinine OR CrCl by Cockcroft-Gault formula ≤1.5 × ULNb ≥45 mL/min for patients with creatinine >1.5 × ULNb Hepatic Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) Coagulation PT/INR aPTT ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal

Patients must be 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial tested a potential cancer therapy to see what dose is safe and effective for patients with solid tumors.

Who is the study for?

Adults with advanced solid tumors who have tried standard treatments or for whom no standard treatment is available. They must have a life expectancy of at least 3 months, measurable disease per RECIST v1.1, and an ECOG performance status of 0 or 1. Tumors must show TROP2 expression and participants should agree to contraception guidelines.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dose of TROP2-CAR-NK cells in patients with advanced solid tumors. It includes a pre-treatment phase with cyclophosphamide and fludarabine phosphate to prepare the body, followed by the experimental NK cell therapy.See study design

What are the potential side effects?

Potential side effects may include reactions from immune system activation such as fever, fatigue, nausea; organ inflammation; blood count changes; infusion-related reactions; and increased risk of infections due to immune suppression from preparatory chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My cancer is advanced, cannot be surgically removed, and has not responded to or I have refused standard treatments.

Select...

My tumor shows high TROP2 levels based on a specific lab test.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I can stay within 100 miles of the study site for the first 4 weeks after treatment.

Select...

I don't have severe breathing problems and my oxygen level is above 92% without extra oxygen.

Select...

If I become pregnant, I will inform my doctor and understand I will be removed from the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 2Experimental Treatment4 Interventions

Participants who are enrolled in Dose Escalation, Participants will be assigned to a dose level of TROP2- CAR-NK cells based on when you join this study. Up to 5 dose levels of TROP2-CARNK cells will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of TROP2-CAR-NK cells is found. Participants who are enrolled in the Dose Expansion, Participants will receive TROP2-CAR-NK cells at the recommended dose that was found in the Dose Escalation.

Group II: Dose Expansion Cohort 1Experimental Treatment4 Interventions

Group III: Dose EscalationExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine phosphate

2007

Completed Phase 2

~360

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bellicum PharmaceuticalsIndustry Sponsor

27 Previous Clinical Trials

1,298 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,422 Total Patients Enrolled

Ecaterina Dumbrava, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned dose escalation as a valid medical practice?

"Dose Escalation's safety is estimated to be a 1 based on its Phase 1 status, as there are limited data points verifying both efficacy and security."

Answered by AI

Is this trial currently open to new participants?

"This research project, which was first posted on March 31st 2024, is not currently accepting participants. As per clinicaltrials.gov's records, the last time this trial sought new enrollees was September 27th 2023; however there are still an abundance of other medical trials actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066424.