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New treatment option for Acute Myeloid Leukemia
Official title CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05672147
What this study is testing
What is Anti-CD33 CAR T-cells?
Anti-CD33 CAR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Anti-CD33 CAR T Cells, Anti-CD33 CAR-T Cells.
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 phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer 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
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to...
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with Study principal investigator (PI) approval
You likely can't join if
- Prior allogeneic transplant if \< 6 months prior to enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current...
- Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped...
- Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation...
- With exception to Hydrea which must be stopped prior to initiation of lymphodepletion
- Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal...
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent...
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with Study principal investigator (PI) approval
- Age: \>= 18 years
- Karnofsky Performance Scale (KPS) \>= 70
- Life expectancy \>= 16 weeks at the time of enrollment
- Prior allogeneic transplant allowed if \> 6 months prior to study enrollment
- Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence
- Relapsed AML is defined as patients that had a first complete response (CR) before developing recurrent disease (increased bone marrow blasts)
- Refractory AML is defined as patients that have not achieved a first CR after induction chemotherapy. For patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of...
- Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML
- CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry. Cytogenetics, flow cytometry, and molecular studies (such as FLT-3 status) will be obtained as per...
- Research participants who are at a high risk of disease recurrence, they must have historical bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML
- No known contraindications to lymphodepleting agents, steroids, tocilizumab and/or cetuximab, or the investigational agent
- Total serum bilirubin =\< 2.0 mg/dL
- Participants with Gilbert syndrome may be included if their total bilirubin is =\< 3.0
- Aspartate aminotransferase (AST) =\< 3 x the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) =\< 3 x ULN
- Estimated creatinine clearance of \>= 60 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis
- Left ventricular ejection fraction \>= 50% within 8 weeks before enrollment
- Oxygen (O2) saturation \> 92% not requiring oxygen supplementation
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- Research participants must have a potential donor or stem cell source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical)
- DONOR: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic hematopoietic stem cell transplantation (alloSCT)
- DONOR: The donor must be HIV negative
- DONOR: KPS \>= 70
- DONOR: Documented body weight
What rules you out
- Prior allogeneic transplant if \< 6 months prior to enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current use of inhaled or topical steroids in standard doses is not...
- Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment
- Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy
- With exception to Hydrea which must be stopped prior to initiation of lymphodepletion
- Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible
- Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis
- people with \>= Grade 2 myelofibrosis on bone marrow biopsy
- people with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening if the patient is undergoing leukapheresis. Patients with controlled atrial arrythmia is allowed
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
- History of stroke or intracranial hemorrhage within 6 months prior to screening
- people with presence of other active malignancy, however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment
- Active viral hepatitis
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, 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 Duarte, California, 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.