AML/MDSPhase 1NCT04318678
CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
A Phase 1 study testing CD123-CAR T, Cyclophosphamide and Fludarabine in people with AML/MDS and B-ALL, run by St. Jude Children's Research Hospital at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 21 years
- What is being tested?
- CD123-CAR T, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2020to 29 Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 39Show fewer
- 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 apheresis
- 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
- 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 planned infusion
- 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 subjects 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
Who cannot join
- 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.
Show all 17Show fewer
- 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 switch and promote CAR T-cell apoptosis).
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Swati Naik, MD, 888-226-4343, referralinfo@stjude.org
Swati Naik, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Paulina Velasquez, MD, 888-226-4343, referralinfo@stjude.org
Paulina Velasquez, MD
About this study
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. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.
Primary Objective:
Read more
- To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.
- To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy.
Secondary Objectives
- To evaluate the antileukemia activity of CD123-CAR T cells.
Exploratory Objectives
- To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells
- To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells
- To characterize tumor cells post CD123-CAR T-cell therapy
- To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells
Read the detailed description
This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells.
This study contains 2 phases. The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase".
The Collection and Manufacturing Phase refers to your blood cells being collected and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells.
The Treatment Phase refers to the portion of the study in which you receive an infusion of the CD123-CAR T cells that were made in the Collection and Manufacturing Phase; chemotherapy is given for several days prior to the cellular infusion. You are then monitored for any possible side effects.
.
Chemotherapy is given to get your body ready to accept the CATCHAML treatment.
Treatment Schedule:
Patients will receive lymphodepleting chemotherapy followed by infusion of CD123-CAR T cells
Fludarabine on day -4, -3 and -2
Cyclophosphamide on day -3 and -2
REST DAY on day -1
CD123-CAR T cell infusion on day 0 or +1
- Being tested
- CD123-CAR T, Cyclophosphamide, Fludarabine, Mesna, Rituximab
- Keywords
- CD123+
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD123-CAR TDrug
Also called CD123-CAR T cells
To treat relapsed/refractory CD123+ AML/MDS, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies.
CyclophosphamideDrug
Also called Cytoxan
Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.
FludarabineDrug
Also called Fludara
Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis
MesnaDrug
Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide
RituximabDrug
Also called Rituxan
Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes
| Study group | Role | What they receive |
|---|---|---|
| ARM A CD123-CAR T cell therapy | Other | For patients who have not received an allogeneic transplant or for patients who have received allogeneic transplant and do not have a transplant donor available
CD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated. Receives: Drug: CD123-CAR T; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Drug: Rituximab |
| ARM B CD123-CAR T cell therapy | Experimental | For patients who relapsed following allogeneic transplant and whose CAR T-cells will be manufactured from the previous transplant donor, when available.
CD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated. Receives: Drug: CD123-CAR T; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of CD123-CAR T cells (CATCHAML)
A phase I design to determine the maximum tolerated dose (MTD) of autologous, CD123- CAR T cells. Four dose levels (3x10^5/kg, 1x10^6/kg, 3x10^6/kg, and 1x10^7/kg) will be evaluated.
Measured: 4 weeks after CD123-CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start29 Jul 2020
- Primary completion29 Jul 2029 (estimated)
- Study completion29 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML/MDSStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Due to review of dose limiting toxicity.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swati Naik, MD, Principal investigator, St. Jude Children's Research HospitalPaulina Velasquez, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318678
- Sponsor's protocol ID
- CATCHAML
- Status last verified
- May 2026
- First submitted
- 20 Mar 2020
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)
- ClinicalTrials.gov ID
- NCT04318678
- Acronym / sponsor ID
- CATCHAML
- Keywords
- CD123+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 29 Jul 2029 (estimated)
- Study completion
- 29 Jul 2030 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.
Primary Objective:
- To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.
- To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy.
Secondary Objectives
- To evaluate the antileukemia activity of CD123-CAR T cells.
Exploratory Objectives
- To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells
- To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells
- To characterize tumor cells post CD123-CAR T-cell therapy
- To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells
Detailed description
This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells.
This study contains 2 phases. The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase".
The Collection and Manufacturing Phase refers to your blood cells being collected and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells.
The Treatment Phase refers to the portion of the study in which you receive an infusion of the CD123-CAR T cells that were made in the Collection and Manufacturing Phase; chemotherapy is given for several days prior to the cellular infusion. You are then monitored for any possible side effects.
.
Chemotherapy is given to get your body ready to accept the CATCHAML treatment.
Treatment Schedule:
Patients will receive lymphodepleting chemotherapy followed by infusion of CD123-CAR T cells
Fludarabine on day -4, -3 and -2
Cyclophosphamide on day -3 and -2
REST DAY on day -1
CD123-CAR T cell infusion on day 0 or +1
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Due to review of dose limiting toxicity.
| Arm | Type | Receives |
|---|---|---|
| ARM A CD123-CAR T cell therapy | Other | Drug: CD123-CAR T, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Mesna, Drug: RituximabFor patients who have not received an allogeneic transplant or for patients who have received allogeneic transplant and do not have a transplant donor available CD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated. |
| ARM B CD123-CAR T cell therapy | Experimental | Drug: CD123-CAR T, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Mesna, Drug: RituximabFor patients who relapsed following allogeneic transplant and whose CAR T-cells will be manufactured from the previous transplant donor, when available. CD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (39 listed)
- 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
Key exclusion criteria (17 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD123-CAR TAlso: CD123-CAR T cellsTo treat relapsed/refractory CD123+ AML/MDS, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies. | Drug | ARM A CD123-CAR T cell therapy, ARM B CD123-CAR T cell therapy |
| CyclophosphamideAlso: CytoxanCyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA. | Drug | ARM A CD123-CAR T cell therapy, ARM B CD123-CAR T cell therapy |
| FludarabineAlso: FludaraFludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis | Drug | ARM A CD123-CAR T cell therapy, ARM B CD123-CAR T cell therapy |
| MesnaMesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide | Drug | ARM A CD123-CAR T cell therapy, ARM B CD123-CAR T cell therapy |
| RituximabAlso: RituxanRituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes | Drug | ARM A CD123-CAR T cell therapy, ARM B CD123-CAR T cell therapy |
Primary outcome
Maximum tolerated dose of CD123-CAR T cells (CATCHAML)
Time frame: 4 weeks after CD123-CAR T-cell infusion
A phase I design to determine the maximum tolerated dose (MTD) of autologous, CD123- CAR T cells. Four dose levels (3x10^5/kg, 1x10^6/kg, 3x10^6/kg, and 1x10^7/kg) will be evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Swati Naik, MD principal investigator
St. Jude Children's Research Hospital
Paulina Velasquez, MD principal investigator
St. Jude Children's Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD123-CAR T, Cyclophosphamide and Fludarabine in people with AML/MDS and B-ALL, run by St. Jude Children's Research Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Swati Naik, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of CD123-CAR T cells (CATCHAML) (time frame: 4 weeks after CD123-CAR T-cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.