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CAR T-cell Therapy
DF9001 + Nivolumab for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Dragonfly Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Awards & highlights
Study Summary
This trial will test a new molecule to target cancer cells and enhance cancer-fighting NK/T-cells. It has two phases, testing in patients with solid tumors. A combo therapy will be used.
Who is the study for?
Adults with various advanced solid tumors expressing EGFR, who have progressed after anti-PD-(L)1 therapy and other standard treatments. They must be able to undergo biopsies, have an ECOG status of 0 or 1, adequate organ function, and use effective contraception. Excluded are those with recent cancer therapies or surgeries, active infections like HIV/Hepatitis B/C, certain autoimmune diseases or severe allergies to monoclonal antibodies.Check my eligibility
What is being tested?
The trial is testing DF9001 alone and in combination with Nivolumab on patients with solid tumors that express EGFR. It has two phases: dose escalation to find the best dose of DF9001 and expansion where this dose is given to more people. The goal is to activate NK cells and T-cells against cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to T-cell activation (like inflammation in organs), infusion reactions from the drug administration process, fatigue from energy depletion by the body's response, digestive issues as a common reaction to drugs affecting rapidly dividing cells such as those in the gut lining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess Overall Response Rate
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Secondary outcome measures
Assess progression-free survival (PFS) for DF9001 per RECIST v1.1.
Assess the best overall response (BOR) per RECIST v1.1.
Assess the duration of response (DOR) per RECIST v1.1.
+6 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Monotherapy DF9001 PK/PD ExpansionExperimental Treatment1 Intervention
Expansion cohorts of monotherapy DF9001 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Group II: Monotherapy DF9001 Expansion in Non-small Cell Lung CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 40 patients with Non-small cell lung cancer (NSCLC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group III: Monotherapy DF9001 Expansion in Head and Neck Squamous Cell CarcinomaExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group IV: Monotherapy DF9001 Expansion in Colorectal CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 40 patients with colorectal cancer (CRC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group V: Monotherapy DF9001 Dose EscalationExperimental Treatment1 Intervention
Dose escalation cohorts of DF9001 in sequential ascending order.
Group VI: Combination PK/PD Expansion with DF9001 and nivolumabExperimental Treatment2 Interventions
Expansion cohorts of DF9001 in combination with a PD-1 checkpoint inhibitor in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Group VII: Combination Expansion of DF9001 and nivolumab in Non-Small Cell Lung CancerExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling up to 40 patients with non-small cell lung cancer (NSCLC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group VIII: Combination Expansion of DF9001 and nivolumab in Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling up to 40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group IX: Combination Expansion of DF9001 and nivolumab in Colorectal CancerExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling up to 40 patients with colorectal cancer (CRC) using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
Group X: Combination Escalation with DF9001 and nivolumabExperimental Treatment2 Interventions
Combination dose escalation of DF9001 in combination with a PD-1 checkpoint inhibitor in patients with select solid tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
953 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ or stem cell transplant.My liver is working well.My cancer has worsened despite treatment for its advanced stage.My colorectal cancer has returned or spread and tests show it has EGFR expression.My cancer is not known to be MMR/MSI high.My cancer progressed after treatment with anti-PD-(L)1 therapy.I do not have significant infections like HIV or active hepatitis.I have a medical history that may increase my risk of side effects from EGFR treatment.I haven't had chemotherapy, major surgery, or experimental drugs within the last 28 days.I have had or currently have inflammation or damage to my cornea.My blood counts are within a healthy range.I do not have severe heart issues, uncontrolled high blood pressure, or serious lung problems.My advanced cancer has EGFR expression and standard treatments have failed.My kidney function is normal.I've had one round of specific chemotherapy for my cancer and, if my cancer is RAS wild-type, I've also had an anti-EGFR antibody treatment.I am mostly active and my doctor expects me to live at least 3 more months.I had a heart or lung stoppage due to a temporary cause that's now gone.I haven't needed strong immune system medications for a long condition, except for stable hormone treatments.I have severe allergies to certain medications or uncontrolled asthma.My cancer is advanced or has spread, tests positive for EGFR, and has not improved with standard treatments.I have never been treated with anti-PD-(L)1 therapy.I have Stage IIIB cancer and cannot undergo curative surgery or radiotherapy.My lung cancer is at an advanced stage and has been tested positive for EGFR.My cancer returned or worsened after initial treatment with specific immune and chemotherapy drugs.I am willing to undergo two biopsies for the study.I have a tumor that can be biopsied for this study.I know my cancer's mutation status and have tried or can't try standard treatments.I am 18 years old or older.My brain metastases are stable, treated, and I don't need steroids.My cancer progressed after treatment with platinum-based chemo and anti-PD-(L)1 drugs.I haven't had cancer other than skin, low-grade prostate, or cervical in situ in the last 3 years.I have or had lung scarring or interstitial lung disease.I have mild side effects from previous treatments, but hair loss, hormone issues, or mild nerve pain is okay.I haven't had cancer treatments, major surgery, or used investigational drugs in the last 28 days.I have had anti-PD-(L)1 therapy without severe side effects.My cancer has returned or spread, is in my head or neck, and tests show it has EGFR.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy DF9001 Dose Escalation
- Group 2: Monotherapy DF9001 PK/PD Expansion
- Group 3: Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma
- Group 4: Monotherapy DF9001 Expansion in Colorectal Cancer
- Group 5: Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
- Group 6: Combination PK/PD Expansion with DF9001 and nivolumab
- Group 7: Combination Expansion of DF9001 and nivolumab in Head and Neck Squamous Cell Carcinoma
- Group 8: Combination Expansion of DF9001 and nivolumab in Colorectal Cancer
- Group 9: Combination Expansion of DF9001 and nivolumab in Non-Small Cell Lung Cancer
- Group 10: Combination Escalation with DF9001 and nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still looking for more people to participate in this experiment?
"According to the latest information found on clinicaltrials.gov, this particular trial is not looking for new patients at this time. The posting date was October 1st, 2022 with the most recent update taking place on October 24th, 2022. There are over 2500 other trials that are currently seeking candidates."
Answered by AI
What is the primary goal of this research?
"The purpose of this study is to assess the overall response rate in patients receiving DF9001 in combination with nivolumab. Secondary objectives include characterizing the pharmacodynamic profile of DF9001 and measuring changes in immune cell activation, assessing the best overall response by IERC, and determining the number, severity, and duration of treatment-related adverse events according to NCI-CTCAE v5.0."
Answered by AI
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