Acute Myeloid Leukemia study: ADCLEC.syn1 CAR T cells vs Conditioning chemotherapy
Official title A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05748197
What this study is testing
What is ADCLEC.syn1 CAR T cells?
An investigational cellular therapy being studied as a potential treatment for relapsed or refractory acute myeloid leukemia (AML).
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 study is testing whether a new cell therapy is safe. It also looks at how well it works for blood cancer.
- Who it's for
- You may be able to join if you have acute myeloid leukemia that has come back or not responded to other treatments.
- What's involved
- You would get a new cell therapy called ADCLEC.syn1. The team will watch you closely for any side effects.
- Time commitment
- The study has two parts to find the right amount and check if it works.
- 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
- Age ≥18 years of age at the time of signing informed consent.
- Patients must have R/R AML. The following disease status will be eligible for the study: a.
- ECOG performance status 0 or 1.
- people must have a suitable stem cell donor identified who may donate cells in the event that the subject needs to undergo an allogeneic HSCT for...
- Serum creatinine \<2.0 mg/100 mL.
You likely can't join if
- Diagnosis of acute promyelocytic leukemia.
- Radiologically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF).
- Oxygen saturation \<90% on room air.
- Patients with prior allogeneic HSCT are allowed as long as HSCT occurred \> 3 months of signing ICF and without ongoing requirement for systemic...
- Treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours...
See the full eligibility criteria
- Age ≥18 years of age at the time of signing informed consent.
- Patients must have R/R AML. The following disease status will be eligible for the study: a. Refractory AML is defined as failure to achieve a CR, CRh or CRi after one of the following regimens: i.
- ECOG performance status 0 or 1.
- people must have a suitable stem cell donor identified who may donate cells in the event that the subject needs to undergo an allogeneic HSCT for rescue from prolonged marrow aplasia.
- Serum creatinine \<2.0 mg/100 mL.
- Total bilirubin \<2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement
- AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.
- Diagnosis of acute promyelocytic leukemia.
- Radiologically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF). people with adequately treated CNS leukemia are eligible.
- Oxygen saturation \<90% on room air.
- Patients with prior allogeneic HSCT are allowed as long as HSCT occurred \> 3 months of signing ICF and without ongoing requirement for systemic graft-versus-host therapy.
- Treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
- Chemotherapy: Bridging chemotherapy including venetoclax must be discontinued at least 1 week prior to administration of conditioning chemotherapy, but FDA-approved oral targeted therapies such as IDH1/2, FLT3, and...
- Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication
- Uncontrolled clinically significant infections such as ongoing fever for 48 hours, persistent bacteremia or requiring new supplemental oxygen.
- Positive serologic test results for HIV.
- Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
- Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR.
- Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \>2 years before screening.
- Live vaccine within 4 weeks prior to leukapheresis
- Pregnant or lactating/breastfeeding women
- Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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, but 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?
This study is enrolling now at Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.