Clinical trial for Leukemia, Myeloid, Acute
Official title CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML
ClinicalTrials.gov ID: NCT05945849
What this study is testing
What is CD33KO-HSPC; CART33?
CD33KO-HSPC; CART33 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leukemia, myeloid, acute.
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
- The purpose of this study is to provide a new type of treatment for AML. This treatment combines a new type of stem cell transplant along with treatment using chimeric antigen receptor (CAR) T cells that have been engineered to recognize and attack your AML cells.
- 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 18 and older
You may be able to join if
- Male or female 18 years of age or older
- people with AML unlikely to be cured with currently available therapies
- AML that has not achieved a complete remission or morphologic leukemia free state by ELN criteria; partial remission or refractory disease (including...
- AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note...
- people with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment.
You likely can't join if
- Pregnant or lactating (nursing) women
- Active hepatitis B or hepatitis C or HIV infection
- Concurrent use of systemic steroids or immunosuppressant medications
- Any uncontrolled active medical disorder that would preclude participation as outlined
- people with signs or symptoms indicative of CNS involvement.
- Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
See the full eligibility criteria
- Male or female 18 years of age or older
- people with AML unlikely to be cured with currently available therapies
- AML that has not achieved a complete remission or morphologic leukemia free state by ELN criteria; partial remission or refractory disease (including primary refractory) are eligible; 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...
- people with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment.
- people must have a suitable stem cell donor.
- Satisfactory organ function
- Creatinine clearance \> 40 ml/min
- ALT/AST must be ≤ 5x upper limit of normal unless related to disease and \< 20 x upper limit of normal if related to disease
- Direct bilirubin \< 2.0 mg/dl, unless subject has Gilbert's syndrome (≤ 3.0 mg/dL)
- Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA
- DLCO \> 45% predicted
- ECOG performance status 0-1
- Written informed consent is given
- people of reproductive potential must agree to use acceptable birth control methods
- Pregnant or lactating (nursing) women
- Active hepatitis B or hepatitis C or HIV infection
- Concurrent use of systemic steroids or immunosuppressant medications
- Any uncontrolled active medical disorder that would preclude participation as outlined
- people with signs or symptoms indicative of CNS involvement.
- Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
- Class III/IV cardiovascular disability according to New York Heart Association Classification
- people with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management, within 2 weeks of the screening/enrollment visit.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.