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New treatment option for Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Official title Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
ClinicalTrials.gov ID: NCT06786533
What this study is testing
What is Anti-FLT3 CAR-T cells?
Anti-FLT3 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia (r/r aml).
Also referred to as HG-CT-1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- people 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...
- AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note...
- AML that has relapsed within 12 months after initial induction and consolidation therapy OR:
You likely can't join if
- 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.
See the full eligibility 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...
- people 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...
- 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...
- 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.
- people 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...
- people 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...
- people of reproductive potential must agree to use acceptable birth control methods (as described in protocol Section 4.7).
- 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.
- people with a history of a prior allogeneic stem cell transplantation are excluded if:
- people are less than 100 days post-transplant OR
- people have evidence of ongoing active GvHD and are taking immunosuppressive agents (\>0.5mg/kg/methylprednisolone equivalents or other immunosuppression for GvHD treatment) OR
- people 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...
- Active or uncontrolled viral, bacterial, or fungal infection. May be receiving ongoing therapy for controlled infection.
- people with signs or symptoms indicative of active CNS involvement. A CNS evaluation shall be performed as clinically appropriate to rule out CNS involvement. people with adequately treated CNS leukemia are eligible...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.