Is NCT07564232 recruiting in Houston, TX?

Yes, NCT07564232 is currently recruiting participants at its Houston, TX location. This clear cell renal cell carcinoma clinical trial is actively enrolling qualified participants.

How do I join the clear cell renal cell carcinoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Clear Cell Renal Cell Carcinoma Clinical Trial in Houston, TX

About This Clear Cell Renal Cell Carcinoma Study in Houston

There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC. The goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Patients with histologically or cytologically confirmed metastatic/advanced RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including at least one PD-1/PD-L1 immune checkpoint inhibitor (ICI) and one tyrosine kinase inhibitor (TKI). Patients with locally advanced disease who are eligible for curative resection are excluded. • For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior lines of therapy, evidence of progression is not required if they stopped treatment for intolerance.

Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. Both overall extent of expression and staining intensity will be scored. Archival tissues that exist prior to the time of enrollment will be used for this purpose.

Patients must have at least one measurable site of disease per RECIST version 1.1.4.

ECOG performance status ≤ 1.

Age ≥ 18 years.

Patients must have adequate organ and marrow function as defined below:

Hemoglobin ≥ 8 g/dl

Absolute neutrophil count ≥1,500/mcL

Platelets ≥100,000/mcL

Total bilirubin ≤ 1.5 mg/dL; for patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN

AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN

Creatinine (CrCl) ≥ 30 mL/min using either the Cockcroft-Gault formula or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation with low molecular weight heparin (LMWH) or direct oral anticoagulant (DOAC) is permitted if the participant is on a stable therapeutic dose for at least 2 weeks at the time of enrollment.

Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan.

For patients with a history of chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, the HBV and HCV viral loads must be undetectable.

Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.

The effects of LNK001 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable

Exclusion Criteria

ary factor which may be one of the following:

Postmenopausal (no menses in greater than or equal to 12 consecutive months).

History of hysterectomy or bilateral salpingo-oophorectomy

Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)

History of bilateral tubal ligation or another surgical sterilization procedure.

Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \> 14 days before starting study drug.

Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the LNK001. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of LNK001. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of LNK001. Approved methods of birth control are as follows:

Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring)

Intrauterine device (IUD)

Tubal Ligation or hysterectomy

Subject/Partner post vasectomy

Implantable or injectable contraceptives, and condoms plus spermicide

Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control

Ability to understand and the willingness to sign a written informed consent document for the clinical trial.

Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing. Exclusion Criteria:

Participants must not have any other malignancies requiring active treatment within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early-stage prostate adenocarcinoma with negligible risk of metastasis or death.

Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after cell infusion (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.

History of major cardiovascular diseases prior to enrollment: unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 6 months prior to consenting, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia, clinically significant pericardial effusions).

Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, or potential need for CNS radiation within the first 28 days from LNK001 therapy. • Patients with treated/stable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or edema for at least 1 month (4 weeks). Patients actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).

Active autoimmune diseases requiring systemic therapy (e.g., with disease-modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy). However, the following will be allowed:

Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.

Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections.

Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \> 10 mg/day or equivalent.

Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

Prior ex vivo, in vivo, autologous or allogeneic CAR T therapy.

Prior treatment with investigational therapeutics that target CAIX or ENPP3.

Severe infection within 4 weeks prior to enrollment (e.g. patients requiring hospitalization, severe sepsis, or severe pneumonia with respiratory failure). • Active ongoing infection requiring oral or IV antimicrobials prior to consenting. Preventive antimicrobials are permitted

Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Pregnant women are excluded from this study because LNK001 is a CAR T agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LNK001, breastfeeding should be discontinued if the mother is treated with LNK001. These potential risks may also apply to other agents used in this study.

Patient is breastfeeding or plans to breastfeed during the study.

Patients with persistent non-hematological grade ≥2 adverse events per NCI CTCAE v6.0 from prior systemic therapies that would confound timely detection of adverse events due to LNK001 or otherwise hinder patient participation in the clinical trial.

History or current evidence of any condition (medical \[including adverse events from prior anticancer therapy, disorders secondary to tumor\], surgical or psychiatric \[including substance abuse\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and/or is not in the best interest of the patient to participate, in the opinion of the treating investigator.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT07564232) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clear Cell Renal Cell Carcinoma Treatment Options in Houston, TX

If you're searching for clear cell renal cell carcinoma treatment options in Houston, TX, this clinical trial (NCT07564232) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced clear cell renal cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clear cell renal cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Clear Cell Renal Cell Carcinoma Clinical Trial in Houston, TX

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