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New treatment option for Refractory Acute Myeloid Leukemia (AML)
Official title CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML
ClinicalTrials.gov ID: NCT07347418
What this study is testing
What is CD64 CAR T Cells?
CD64 CAR T Cells is an investigational medicine, being studied as a potential treatment for 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 is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains in subjects with refractory or relapsed (R/R) acute myeloid leukemia (AML). This CAR T cell product will be referred to as "CD64 CAR T" which is CD64 directed, autologous, genetically modified CAR T 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
- ≥ 18 years of age.
- people must have one of the following diagnoses per the International Consensus Classification (ICC) 2022 criteria: a. Acute Myeloid Leukemia (AML).
- Refractory OR relapsed AML: a. Refractory disease i. ≥5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry, or...
- people must have received at least one prior line of therapy, including at least one line of therapy containing Ven.
- Documentation of CD64 expression on ≥70% of myeloid blasts by flow cytometry after the most recent relapse, as determined by standardized and...
You likely can't join if
- people with Acute Promyelocytic Leukemia (APL) with t(15;17)
- Receipt of previous chemotherapy for AML, as follows: a. Prior to apheresis, the following washout periods apply: i. Hydroxyurea: 1 day ii...
- Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with...
- Previous treatment with investigational gene or cell therapy (including CAR therapy).
- Signs or symptoms indicative of CNS leukemia involvement. A CNS evaluation should be performed if CNS involvement is suspected to rule out CNS...
- Pregnant or lactating (nursing) women.
See the full eligibility criteria
Who can join
- ≥ 18 years of age.
- people must have one of the following diagnoses per the International Consensus Classification (ICC) 2022 criteria: a. Acute Myeloid Leukemia (AML).
- Refractory OR relapsed AML: a. Refractory disease i. ≥5% blasts in the bone marrow or peripheral blood by morphology, flow cytometry, or immunohistochemistry after a minimum of 1 cycle of a hypomethylating agent (HMA)...
- people must have received at least one prior line of therapy, including at least one line of therapy containing Ven.
- Documentation of CD64 expression on ≥70% of myeloid blasts by flow cytometry after the most recent relapse, as determined by standardized and validated multiparameter flow cytometry assay (Hematologics, Inc., Seattle...
- Total white blood cell (WBC) count ≤ 25 x 10(to the 9th)/L prior to apheresis. Hydroxyurea is permitted to achieve this
- Absolute lymphocyte count (ALC) ≥ 200/µL prior to apheresis OR ALC \< 200 µL with concurrent lymphocyte subset analysis (CD3, CD4, and CD8 counts) confirming an absolute CD3 count ≥ 150/µL.
- Confirmed availability of cells for a rescue stem cell transplant AND subject must be deemed an appropriate candidate for such therapy per institutional standards.
- people who have undergone prior allogeneic stem cell transplant must be ≥ 6 months out from transplant and be off systemic immunosuppression for at least 1 month at the time of enrollment with no evidence of active...
- Adequate organ function, defined as:
- Creatinine clearance ≥ 30 mL/min, based on the CKD-EPI Creatinine Equation (2021).
- AST/ALT ≤ 5x upper limit of the normal range, unless considered to be due to leukemic involvement.
- Bilirubin ≤ 3x upper limit of the normal range, unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement.
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air, unless considered to be due to leukemic involvement.
- Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA.
- ECOG performance status 0, 1, or 2.
- Signed informed consent form.
- people of reproductive potential must agree to use acceptable birth control methods, as described in the protocol main text.
- Willing to participate in the long-term follow-up protocol that is required if CAR T cell therapy is administered.
What rules you out
- people with Acute Promyelocytic Leukemia (APL) with t(15;17)
- Receipt of previous chemotherapy for AML, as follows: a. Prior to apheresis, the following washout periods apply: i. Hydroxyurea: 1 day ii. Hypomethylating agent and/or venetoclax: 7 days iii. Small molecule targeted...
- Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.
- Previous treatment with investigational gene or cell therapy (including CAR therapy).
- Signs or symptoms indicative of CNS leukemia involvement. A CNS evaluation should be performed if CNS involvement is suspected to rule out CNS leukemia involvement.
- Pregnant or lactating (nursing) women.
- Known HIV infection or active Hepatitis B or Hepatitis C infection.
- Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- people with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
- people with cardiac arrhythmia, or arrhythmias that are not stable with medical management, within 2 weeks of the Screening/Enrollment visit.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- Evidence of another uncontrolled malignancy. Apheresis Eligibility To proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21 days prior to apheresis, unless...
- CD64 CAR T must have met manufacturing criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA)
- Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).
- Performance status determination (ECOG must be 0, 1 or 2).
- Participant remains clinically stable without evidence of vital sign instability including the lack of supportive vasoactive drugs or intensive care support.
- Must not have ALT/SGPT and AST/SGOT \> 10x the ULN or total bilirubin \> 3x the ULN, (unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement)
- Adequate renal function, as defined in the Inclusion Criteria.
- No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, 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 Aurora, Colorado, 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.