Is NCT05773040 recruiting in Houston, TX?

Yes, NCT05773040 is currently recruiting participants at its Houston, TX location. This lymphomas clinical trial is actively enrolling qualified participants.

How do I join the lymphomas 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.

Lymphomas Clinical Trial in Houston, TX

Who Can Participate

Inclusion Criteria

Patients must meet the following inclusion criteria in order to be eligible for participation in this trial:

For the dose escalation cohort: Eligible patients will include those with r/r B-cell lymphoma including LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL), FL, marginal zone lymphoma, and MCL after at least 2 prior systemic therapies and Burkitt lymphoma after at least 1 prior systemic therapy. For the dose expansion cohort: Patients with r/r LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL) and FL grade 3B will be eligible

Received at least 2 prior lines of therapy, including anti-CD20 antibody and anthracycline therapy for LBCL, anti-CD20 antibody and alkylating agent or lenalidomide therapy for FL, anti-CD20 antibody and alkylating agent or lenalidomide or BTK inhibitor therapy for marginal zone lymphoma, and anti-CD20 antibody and alkylating agent or BTK inhibitor therapy for MCL. Patients with Burkitt lymphoma may be eligible after 1 line of prior therapy including anti-CD20 antibody and anthracycline therapy.

Patients who have received prior CD19 CAR cell therapy using FMC63 antibody for targeting CD19 are eligible and must be at least 6 weeks post CAR infusion and have \<5% of peripheral blood T cells expressing the prior CAR by flow cytometry assessment.

≥18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

At least one measurable lesion per the Lugano 2014 Classification53

At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic anti-cancer therapy prior to leukapheresis. For patients treated with monoclonal antibody-based therapies, at least 4 weeks must have elapsed prior to leukapheresis.

Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia)

Absolute neutrophil count of ≥1.0×10\^9/L

Absolute lymphocyte count of ≥0.1×10\^9/L

Platelet count of ≥75×10\^9/L

Creatinine clearance (as estimated by Cockcroft Gault) ≥45 mL/min

Serum alanine transaminase (ALT) / aspartate transaminase (AST) ≤5 times the upper limit of normal (ULN)

Total bilirubin ≤2 mg/dL, except in patients with Gilbert's syndrome.

Cardiac ejection fraction ≥45% with no evidence of clinically significant pericardial effusion

Baseline oxygen saturation ≥92% on room air

Women of childbearing potential must have a negative serum or urine pregnancy test (women who have had hysterectomy and women who are over the age of 45 years and

Exclusion Criteria

Patients will be excluded from participating in the trial if he/she has:

Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients with prior CNS lymphoma that has been effectively treated will be eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.

Any CAR cell therapy using non-FMC63 antibody.

History of Richter's transformation of chronic lymphocytic leukemia

Autologous stem cell transplantation within 6 weeks.

Allogeneic stem cell transplantation within 3 months or active graft versus host disease.

Active autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppression/systemic disease modifying agents within the last 1 year or inflammatory disease (including graft versus host disease) requiring systemic immunosuppressive therapy. Physiological replacement of corticosteroids of up to 7.5 mg of prednisone or equivalent per day, and topical and inhaled corticosteroids are permitted.

History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy of the CAR-T product.

History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years and treated with curative intent. Patients with a prior history of malignancy whose natural history or treatment (e.g. hormonal therapy) does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen in the opinion of the investigator may be included.

Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis or localized skin infections are permitted if responding to active treatment and after consultation with the Principal Investigator.

Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.

History or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Patients with cardiac atrial or cardiac ventricular lymphoma involvement

Requirement for urgent therapy due to tumor mass effect such as bowel obstruction or blood vessel compression

Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

Live vaccine ≤6 weeks prior to planned start of conditioning regimen

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning chemotherapy on the fetus or infant.

Females of childbearing potential and males of child fathering potential who are not willing to practice two methods of birth control from the time of consent through 6 months after infusion of the study drug

In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

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 (NCT05773040) 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.

Lymphomas Treatment Options in Houston, TX

If you're searching for lymphomas treatment options in Houston, TX, this clinical trial (NCT05773040) 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 clinical trial. You'll receive care from experienced lymphomas 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 lymphomas clinical trials near you to find additional studies recruiting in your area.

Lymphomas Clinical Trial in Houston, TX

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