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CAR T-cell Therapy

KSQ-001EX for Solid Tumors

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.

Must not have

Prior organ allograft or prior cell therapy that included LDC or myeloablative chemotherapy regimen. Known hypersensitivity to any component of KSQ-001EX or excipient including dimethyl sulfoxide, human serum albumin, LDC regimen (cyclophosphamide or fludarabine) or IL-2 (as applicable). Active or prior documented autoimmune or inflammatory disorders. Uveal and/or ocular melanoma. Large cell neuroendocrine NSCLC. Symptomatic and/or untreated brain metastases. Women who are pregnant or nursing. Seropositive for HIV 1 or 2 or active infection with HBV or HCV. Any form of primary immunodeficiency. Any known clinically significant or concurrent acute liver disease. Previous solid organ or hematopoietic cell transplant. Need for treatment with steroids at stable doses. Live or unattenuated vaccine < 28 days prior to first dose of LDC regimen. History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to first dose of study treatment. Symptomatic congestive heart failure according to NYHA classification, Class III or IV, unstable angina pectoris, clinically significant cardiac arrhythmia, or left ventricular ejection fraction < 45%. Prolongation of QT/QTc interval. Unable to walk a distance of 80% predicted for age and sex or develop hypoxia during a 6-minute walk test. Obstructive or restrictive pulmonary disease. Treatment on another study with other investigational therapeutic interventional study within 28 days to start of LDC regimen. Known additional malignancy that is active and/or progressive requiring treatment. Psychiatric illness that would limit compliance with study requirements. Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~840

Fludarabine

2012