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CAR T-cell Therapy

Arm 1: Phase 1- Safety Lead-in (Cohort 1) for Lung Cancer

Phase 1 & 2

Recruiting

Led By Rodabe N Amaria, MD

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

Resectable lesion(s) for KSQ-001EX manufacturing (tumor ≥1.5cm2 or at least 5 core biopsies). At least 1 measurable lesion per RECIST v1.1 following tumor resection for KSQ-001EX manufacturing. Age between 18 - 70 years old. Life expectancy of ≥ 12 weeks. Recovered to ≤ Grade 1 or Baseline toxicity (except alopecia, neuropathy, and endocrinopathies from prior immunotherapy) from prior therapy. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Adequate bone marrow function, renal function, and hepatic function. Washout period from prior anticancer therapy(ies) of a minimum duration required prior to the first study treatment. Female participants who are women of childbearing potential must confirm a negative pregnancy test and agree to the use of a highly effective contraceptive method or at least 2 effective methods at the same time during the study treatment period and for up to 3 months after study treatment. Male participants must be willing to use effective barrier contraception during the study treatment period and for up to 3 months after study treatment. Capable of understanding and complying with protocol requirements. Signed and dated Institutional Review Board (IRB) approved informed consent form before any protocol-directed Screening procedures are performed.

Diagnosed with histologically and/or cytologically confirmed primary diagnosis of NSCLC which has progressed on standard therapy which includes treatment with platinum-based chemotherapy and checkpoint inhibitor therapy (either given in combination or sequentially). Participants with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy in addition to platinum-based chemotherapy.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

"This trial aims to determine if KSQ-001EX is safe for patients with advanced solid tumors."

Who is the study for?

This trial is for people with advanced solid tumors, including melanoma, lung cancer, and head and neck cancers. Participants must meet certain health standards to be eligible.Check my eligibility

What is being tested?

The safety of KSQ-001EX (engineered tumor-fighting cells) is being tested in patients with advanced solid tumors. The treatment includes a preparation phase with drugs like Interleukin-2, Cyclophosphamide, and Fludarabine before receiving KSQ-001EX.See study design

What are the potential side effects?

Potential side effects may include reactions from the immune system's activation such as fever or fatigue, chemotherapy-related nausea or hair loss, and possible unique effects from the engineered cells.

Eligibility Criteria

Inclusion Criteria

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

Select...

My NSCLC has worsened despite standard treatments, including platinum-based chemo and checkpoint inhibitors.

Select...

I have HNSCC, treated with 1-3 therapies including platinum and anti-PD-1/PD-L1.

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

Safety and adverse events (AEs)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3: Phase 2- Expansion PhaseExperimental Treatment3 Interventions

It is expected that approximately 20 participants will be enrolled in each of the 3 indication specific cohorts.

Group II: Arm 2: Phase 1- Safety Lead-in (Cohort 2)Experimental Treatment4 Interventions

Patients in Cohort 2 will receive IL-2 dosing (600,000 international units [IU]/kg administered every 8 to 12 hours for up to 6 doses, as tolerated).

Group III: Arm 1: Phase 1- Safety Lead-in (Cohort 1)Experimental Treatment3 Interventions

Approximately 6 patients with melanoma, NSCLC or HNSCC will be enrolled in the Safety Lead-in phase of the study with a KSQ-001EX dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Interleukin-2

1994

Completed Phase 3

~700

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,324 Total Patients Enrolled

KSQ Therapeutics, Inc.Industry Sponsor

1 Previous Clinical Trials

140 Total Patients Enrolled

Rodabe N Amaria, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

42 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants still eligible to enroll in this ongoing clinical trial?

"The current status of this clinical trial, as documented on clinicaltrials.gov, indicates that patient recruitment is not ongoing. Initially shared on July 31st, 2024, the latest update was made on January 25th, 2024. Despite this trial no longer accepting participants, there are a substantial number of other studies actively seeking enrollees - precisely 4915 at present."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"In order to be considered for this research, individuals must have a diagnosis of melanoma and fall within the age bracket of 18 to 70 years. The study has availability for up to 72 eligible participants."

Answered by AI

Is the research study open to participants who are under 20 years old?

"Participants aged between 18 and 70 are being sought for enrolment in this clinical investigation. It is worth noting that there are a considerable number of trials available specifically for individuals under 18 years old as well as those over the age of 65, with figures standing at 395 and 4711 respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

2024. "A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06237881.

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