Is NCT05110742 recruiting in Houston, TX?

Yes, NCT05110742 is currently recruiting participants at its Houston, TX location. This hematological malignancy clinical trial is actively enrolling qualified participants.

How do I join the hematological malignancy 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.

Hematological Malignancy Clinical Trial in Houston, TX

About This Hematological Malignancy Study in Houston

To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry.

Patients must meet diseases specific eligibility criteria (see below)

Patients should be at least 1 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy.

Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.

Karnofsky Performance Scale \> 50%.

Adequate organ function:

Renal: Serum creatinine ≤ 2.0ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml/min/1.73 m2.

Hepatic: ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver cirrhosis.

Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.

Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \> 92% on room air.

Able to provide written informed consent.

18-80 years of age.

Weight ≥40 kg.

English and non-English speaking patients are eligible.

All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.

Signed consent to long-term follow-up protocol PA17-0483.

Disease specific inclusion criteria A. T-cell non-Hodgkin's lymphoma and T-cell acute lymphoblastic leukemia

Patients with history of T-lymphoid malignancies, defined as acute lymphoblastic leukemia (ALL/T-LBL), Peripheral T-cell lymphoma (PTCL-NOS), MF/SS, Hepatosplenic gamma/delta NHL, AITL, ALCL, or other subtypes of T cell NHL, T-PLL, Mixed phenotypic leukemia (MPAL) with CD5 expression who have received at least 2 lines of standard chemo-immunotherapy or targeted therapy and have measurable persistent disease. For T-ALL active disease defined as (\>5% of blasts or positive MRD at a level of \>0.1% measured by multiparameter flow cytometry).

Patients with history of T-lymphoid malignancies as defined above with relapsed disease following standard therapy or a stem cell transplant. B. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL) small lymphocytic lymphoma (SLL), Richter's transformation of CLL or SLL who have received at least 2 lines of standard therapy or targeted therapy to include chemoimmunotherapy e.g. FCR, BTK inhibitors and a BCL-2 inhibitor and have persistent disease. C. Mantle cell lymphoma Relapsed or refractory mantle cell lymphoma after 2 lines of standard chemoimmunotherapy including a BTKi.

Exclusion Criteria

Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.

Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.

Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.

Active hepatitis B or C.

HIV with detectable viral load.

Presence of active neurological disorder(s).

Active autoimmune disease within 12 months of enrollment

Active cerebral or meningeal involvement by the malignancy

Active (defined as requiring therapy) acute or chronic GVHD.

Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.

Presence of any other serious medical condition that may endanger the patient at investigator criteria.

Major surgery \<4 weeks prior to first dose of study drug

Allogeneic SCT or DLI \<12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior enrollment in the study.

Concomitant use of other investigational agents.

Concomitant use of other anti-cancer agents.

Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of enrollment.

Patients receiving immunosuppressive therapy.

Patients with diminished mental capacity will not be enrolled on the study.

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 (NCT05110742) 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.

Hematological Malignancy Treatment Options in Houston, TX

If you're searching for hematological malignancy treatment options in Houston, TX, this clinical trial (NCT05110742) 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 hematological malignancy 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 hematological malignancy clinical trials near you to find additional studies recruiting in your area.

Hematological Malignancy Clinical Trial in Houston, TX

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