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New treatment option for AML/MDS
Official title CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
ClinicalTrials.gov ID: NCT04318678
What this study is testing
What is CD123-CAR T?
CD123-CAR T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml/mds.
Also referred to as CD123-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
- The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients.
- 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 up to 21
You may be able to join if
- for Procurement and T-cell Production:
- Age ≤21 years old
- Relapsed/refractory CD123+ disease defined as follows: AML/MDS
- Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)
- Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy B-cell ALL
You likely can't join if
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
- History of hypersensitivity reactions to murine protein-containing products
- Patients with acute promyelocytic leukemia (APL, t (15;17))
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. Inclusion Criteria for Treatment:
See the full eligibility criteria
- for Procurement and T-cell Production:
- Age ≤21 years old
- Relapsed/refractory CD123+ disease defined as follows: AML/MDS
- Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)
- Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy B-cell ALL
- Relapsed disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies including
- Patients in 2nd or greater relapse
- Patients with relapse after allogeneic HSCT
- Refractory disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies T-cell All Relapsed refractory disease that is CD123 positive BPDCN
- Relapsed/refractory disease that has failed front-line therapy
- Estimated life expectancy of \>12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥50
- Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to...
- Patient must have an identified, suitable HCT donor
- For females of child-bearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
- History of hypersensitivity reactions to murine protein-containing products
- Patients with acute promyelocytic leukemia (APL, t (15;17))
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. Inclusion Criteria for Treatment:
- Age≤21 years old
- Detectable disease that is CD123+ (at least MRD+ disease)
- Estimated life expectancy of \>8 weeks
- Karnofsky or Lansky (age-dependent) performance score≥50
- Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to...
- Patient must have an identified, suitable HCT donor
- Adequate cardiac function defined as left ventricular ejection fraction \>40%, OR shortening fraction ≥25%
- EKG without evidence of clinically significant arrhythmia
- Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml/min/1.73m2 (GFR ≥40 ml/min/1.73m2 if \< 2 years of age)
- Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing
- Total Bilirubin≤3 times the upper limit of normal for age, except in people with Gilbert's syndrome
- Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age
- Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
- For females of child-bearing age
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- If sexually active, agreement to use birth control until 3 months after T- cell infusion. Male partners should use a condom.
- Available autologous transduced T-cell product that has met GMP release criteria Exclusion Criteria:
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent uncontrolled bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- History of severe hypersensitivity reactions to cornstarch or hydroxyethyl starch.
- Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to CD123-CAR T- cell infusion
- Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))
- Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion. (This exclusion criterion is intended to prevent premature exposure of CD123-CAR T cells to rituximab, which would activate the safety...
- Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion.
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide.
- Active CNS disease
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, 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, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, 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.