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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

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 weeks
Treatment ~ Varies
Follow Up ~from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months. for reporting.

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
Number of patients with AEs and TRAEs.
+1 more
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.
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Monotherapy DF9001 Expansion in Renal Cell CarcinomaExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group II: Monotherapy DF9001 Expansion in Non-small Cell Lung CancerExperimental Treatment1 Intervention
Monotherapy expansion cohort enrolling up to 20-40 patients with Non-small cell lung cancer (NSCLC) using the recommended phase 1b dose (REED) 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 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group IV: Monotherapy DF9001 Dose EscalationExperimental Treatment1 Intervention
Dose escalation cohorts of DF9001 in sequential ascending order.
Group V: Combination Expansion of DF9001 and pembrolizumab in Renal Cell CarcinomaExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Group VI: Combination Expansion of DF9001 and pembrolizumab in Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions
Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KEYTRUDA®
2018
Completed Phase 2
~70
pembrolizumab
2017
Completed Phase 3
~5750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immunotherapy for solid tumors often involves targeting natural killer (NK) cells and T-cell activation signals to enhance the body's immune response against cancer cells. Treatments like those studied in the DF9001 trial aim to direct these immune cells to specific receptors on cancer cells, thereby improving their ability to recognize and destroy malignant cells. This approach is crucial for solid tumor patients as it offers a targeted method to combat cancer, potentially leading to more effective and less toxic treatments compared to traditional chemotherapy. By harnessing the body's own immune system, these therapies can provide durable responses and improve overall survival rates.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,021 Total Patients Enrolled
Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
953 Total Patients Enrolled

Media Library

DF9001 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05597839 — Phase 1 & 2
Solid Tumors Research Study Groups: Combination Expansion of DF9001 and pembrolizumab in Renal Cell Carcinoma, Monotherapy DF9001 Expansion in Renal Cell Carcinoma, Combination Expansion of DF9001 and pembrolizumab in Head and Neck Squamous Cell Carcinoma, Monotherapy DF9001 Dose Escalation, Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma, Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
Solid Tumors Clinical Trial 2023: DF9001 Highlights & Side Effects. Trial Name: NCT05597839 — Phase 1 & 2
DF9001 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597839 — Phase 1 & 2
~91 spots leftby Aug 2025