Is NCT06786533 recruiting in Houston, TX?

Yes, NCT06786533 is currently recruiting participants at its Houston, TX location. This relapsed/refractory acute myeloid leukemia (r/r aml) clinical trial is actively enrolling qualified participants.

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.

Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Clinical Trial in Houston, TX

Q: How do I join the relapsed/refractory acute myeloid leukemia (r/r aml) 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.

About This Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Study in Houston

This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety. Up to 18 evaluable adult and 18 evaluable pediatric subjects will be enrolled. Evaluable subjects are defined as those who have received an infusion of HG-CT-1. Primary clinical objectives: i. Determine the safety of HG-CT-1 based on the proportion of subjects infused with HG-CT-1 who experience a dose limiting toxicity (DLT). Secondary clinical objectives: i. Estimate the efficacy of HG-CT-1 according to standard clinical response criteria for AML. ii. Estimate overall survival of evaluable subjects. iii. Estimate progression-free survival of evaluable subjects. iv. Estimate duration of response in evaluable subjects who achieve a response. Secondary scientific objectives: i. Describe the persistence and trafficking of HG-CT-1. ii. Describe HG-CT-1 bioactivity and its predictors.

Sponsor: Hemogenyx Pharmaceuticals LLC

Who Can Participate

Inclusion Criteria

18 years of age or older at enrollment. Patients ≥12 and \<18 12 to 17 years of age weighing ≥ 35 kg at enrollment may be included once safety evaluation at the corresponding adult dose escalation protocol have been completed.

Subjects with AML unlikely to be cured with currently available therapies. Specifically, the following groups are eligible:

Refractory AML: i.e., newly diagnosed AML that after two cycles of intensive chemotherapy has not achieved a complete remission or morphologic leukemia free state by ELN criteria.1 Intensive chemotherapy must have included either the combination of cytarabine and an anthracycline (7+3 or similar) or combination of venetoclax with a hypomethylating agent. Patients with FLT3 ITD must also have failed treatment with a FLT3 inhibitor and patients with IDH1 or IDH2 mutations must have failed treatment containing ivosidenib or enasidenib respectively (i.e., progression on treatment, or failure to achieve CR after six months of treatment,) OR:

AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note: morphologic relapse is not required; persistent/recurrent disease-associated molecular, phenotypic, or cytogenetic abnormalities (measurable residual disease, MRD) at any time after allogeneic HSCT is eligible. OR:

AML that has relapsed within 12 months after initial induction and consolidation therapy OR:

AML that has relapsed more than 12 months after initial induction but that has failed to achieve CR or morphologic leukemia free state after one reinduction OR:

AML after second or subsequent relapse.

FLT3 expression must be detectable in AML blast by flow cytometric analysis.

Subjects must have a suitable stem cell transplant donor. Donor may be matched or mismatched and must be found to be suitable according to the institution's standard criteria. That donor shall be "cleared" for donation by institutional standards prior to administration of HG-CT-1. Adult donors can be either related or unrelated, HLA-matched or partially matched. Matched or partially matched umbilical cord blood donors are also eligible.

Subjects with relapsed disease after prior allogeneic transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment without GvHD that requires systemic immunosuppression.

Satisfactory organ functions:

Creatinine ≤ 1.6 mg/dl and Creatinine clearance (CrCl) as calculated by the Cockcroft-Gault formula ≥ 60 mL/min.

ALT/AST must be ≤ 3 x upper limit of normal unless related to disease.

Direct bilirubin \< 2.0mg/dl unless subject has Gilbert's syndrome (in which case it should be ≤3.0 mg/dL).

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

DLCO \>45% predicted and O2 Saturation \> 90% on room air.

Patients ≥18 must have an ECOG Performance status 0-1. Patients \<18 must have a Lansky/Karnofsky score of ≥50.

Written informed consent is given in patients ≥ 18. In patients \<18 or not developmentally appropriate for consent, written consent will be provided to the parent or legal guardian. Patients ≥12 and \<18 years of age will be additionally provided with assent documentation.

Subjects of reproductive potential must agree to use acceptable birth control methods (as described in protocol Section 4.7).

Exclusion Criteria

Pregnant or lactating (nursing) women.

Active second malignancy will not be eligible with the following exceptions:

Carcinoma in situ of the cervix (which may be considered for enrollment),

Indolent, non-metastatic prostate cancer

Non melanoma skin cancer

Other indolent and controlled malignancies not requiring urgent treatment.

Subjects with a history of a prior allogeneic stem cell transplantation are excluded if:

Subjects are less than 100 days post-transplant OR

Subjects have evidence of ongoing active GvHD and are taking immunosuppressive agents (\>0.5mg/kg/methylprednisolone equivalents or other immunosuppression for GvHD treatment) OR

Subjects have received DLI within 30 days prior to enrollment.

Active hepatitis B (HBV) or active hepatitis C (HCV) or any HIV infection. Note: prior HCV that has been appropriately treated or evidence of past HBV infection do not constitute exclusions.

Concurrent use of systemic steroids at a prednisone dose of greater than 10 mg, hydrocortisone greater than 10-12.5 mg/m2/day, or equivalent. Recent, or current use of inhaled steroids is not exclusionary.

Concurrent use of immunosuppressant medications such as calcineurin inhibitors, methotrexate, or alemtuzumab.

Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the site Pl would pose an unacceptable risk to the subject.

Active or uncontrolled viral, bacterial, or fungal infection. May be receiving ongoing therapy for controlled infection.

Subjects with signs or symptoms indicative of active CNS involvement. A CNS evaluation shall be performed as clinically appropriate to rule out CNS involvement. Subjects with adequately treated CNS leukemia are eligible. History of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture and negative imaging (imaging required only if previously showing evidence of CNS leukemia not otherwise documented by spinal fluid assessment).

Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).

Hyperleukocytosis (\>50,000 blasts/µL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.

Patients with Acute Promyelocytic Leukemia are not eligible.

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 (NCT06786533) 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.

Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treatment Options in Houston, TX

If you're searching for relapsed/refractory acute myeloid leukemia (r/r aml) treatment options in Houston, TX, this clinical trial (NCT06786533) 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 relapsed/refractory acute myeloid leukemia (r/r aml) 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 relapsed/refractory acute myeloid leukemia (r/r aml) clinical trials near you to find additional studies recruiting in your area.

Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Clinical Trial in Houston, TX

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