Acute Lymphoblastic Leukemia, in RelapsePhase 1CAR-20/19-TNCT04049383
CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL
A Phase 1 study testing CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg) and CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia With Failed Remission, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent
- What is being tested?
- CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg) and CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 1 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of B-cell ALL: During the safety phase patients enrolled will be age ≥ 18 to age ≤ 70. Once those three patients have passed the 28-day waiting period post infusion, clearance from the FDA will be obtained to enroll pediatric patients. After FDA clearance -Patients must be aged ≥ 1 year and ≤ 70 years. All patients will have relapsed, refractory disease and no available curative options that meet clinical criteria to initiate treatment.
- Relapsed or refractory B cell ALL defined as one of the following:
- Primary refractory disease.
- Relapsed or refractory disease after two or more lines of systemic therapy.
- Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least four weeks prior to enrollment.
- Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, or cytogenetics, or morphological disease in the bone marrow.
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- Subjects with B-cell ALL must have either CD19 or CD20 positive disease on their most recent bone marrow performed. A minimum of 5% CD19 or CD20 positivity on prior biopsy or bone marrow aspiration (BMA) is required.
- Subjects with Ph+ ALL are eligible if they have relapsed or refractory disease and have failed at least two tyrosine kinase inhibitors.
- Absolute cluster of differentiation 3 (CD3)+ T cell count ≥100/mm^3.
- Subjects who receive chemotherapy and/or steroids after CD3+ T-cell count, but before apheresis, will require this test to be repeated.
- Lumbar puncture with CSF analysis by cytology with no evidence of disease.
- Karnofsky/Lansky performance score ≥70.
- Normal Baseline Neurological Evaluation: Mini-Mental Status Exam Score 24-30.
- Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) <3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <2 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.
- Adequate renal function defined as creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 ml/min/1.73 M2
- Able to give informed consent if > 18 years, or with a legal guardian capable of giving informed consent if < 18 years.
- Agree to practice birth control during the study.
- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
- No clinically significant arrhythmias.
- Adequate pulmonary function as indicated by room air oxygen saturation of ≥92% and no clinically significant pleural effusion.
- Expected survival >12 weeks.
- Negative urine or serum pregnancy test in females of child bearing potential at study entry and again within 48 hours' prior to lymphodepleting chemotherapy.
- Subjects with prior CD19 or CD20 therapy (e.g. blinatumomab, CART19, rituximab) treatment require repeat BMA post-CD19 or CD20 therapy treatment that demonstrates CD19 or CD20 positive disease.
- Meet criteria for regarding fertility and contraception. Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.
- Condoms (male or female) with or without a spermicidal agent.
- Diaphragm or cervical cap with spermicide.
- Intrauterine device (IUD).
- Hormonal-based contraception.
- Central line access will be required for CAR-20/19-T cell infusion.
Who cannot join
- Positive beta-human chorionic gonadotropin (HCG) in female of childbearing potential.
- Subjects with known systemic allergy to bovine or murine products.
- Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy defined as >20 mg of prednisone.
- Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5 from any previous treatment unless it is felt to be due to underlying disease.
- Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution.
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- Refusal to participate in the long-term follow-up protocol.
- Central nervous system (CNS) Abnormalities:
- Subjects with prior CNS disease that has been effectively treated will be eligible providing treatment was > four weeks before enrollment and a remission documented within four weeks of planned CAR-T cell infusion. Subjects will be excluded if they have any signs of neurotoxicity at baseline or evidence of chloroma or leukemic infiltrates on MRI.
- Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 white blood cells (WBCs) per mm^3 with or without neurological changes, and presence of CNS-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with < 5 WBCs per mm^3 with neurological changes will be excluded.
- Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study. History or presence of any CNS disorder, such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema are excluded.
- Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.
- Anti-CD20 antibody treatment within four weeks of cell infusion.
- Anti-CD19 antibody treatment within four weeks of cell infusion.
- Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion.
- Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within seven days prior to apheresis collection for CAR-T cells. Tyrosine kinase inhibitors (TKIs) must be held for five half lives or seven days whichever is shorter prior to enrollment.
- Subjects post solid organ transplant who develop high grade lymphomas or leukemias.
- Concurrent active malignancy (exceptions: treated solid malignancy in > five years' remission, treated basal or squamous cell carcinomas of the skin).
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome
- No rapidly escalating ALL disease (please discuss with the principal investigator).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Phase 1 Study of Redirected Autologous T Cells Engineered to Contain an Anti-CD19 and Anti-CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed/ Refractory CD19 or CD20 B-cell Acute Lymphoblastic Leukemia
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Read the detailed description
This is a phase 1, interventional, open label, treatment study designed to evaluate the safety and feasibility of infusion of CAR-20/19-T in subjects with B cell ALL who have relapsed after prior therapies or refractory disease and are not candidates for curative intent standard therapy. There will be two phases of this study. First, a dose escalation phase will determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level.
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia
- Being tested
- CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg), CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg), CAR-20/19-T cells
- Keywords
- Acute Lymphoblastic Leukemia, B-cell, CAR-T
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)Biological
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level -1: 5 x 10^5 CAR-20/19-T cells/kg
CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)Biological
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level 0: 1 x10^6 CAR-20/19-T cells/kg (starting dose level)
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)Biological
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
Dose Level 1: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)
CAR-20/19-T cellsBiological
The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design.
The dose expansion dose level is still to be determined and this section will be updated.
| Study group | Role | What they receive |
|---|---|---|
| 5 x 10^5 CAR-20/19-T cells/kg | Experimental | The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Receives: Biological: CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg) |
| 1 x10^6 CAR-20/19-T cells/kg | Experimental | The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Receives: Biological: CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg) |
| 2.5 x10^6 CAR-20/19-T cells/kg | Experimental | The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Receives: Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) |
| Dose Expansion Phase | Experimental | The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Subjects will receive one of three dose levels. The dose expansion arm will be updated with the appropriate dose in the future based on the escalation results. Receives: Biological: CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg); Biological: CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg); Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg); Biological: CAR-20/19-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events after CAR 20/19-T Cell Infusion.
Adverse events will be measured and recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Occurrence of adverse events, defined as either CRS related Grade 3/4 toxicity or other NCI CTCAE version 5 non-hematologic ≥ grade 3 signs/symptoms, laboratory toxicities and clinical events that are possibly, probably or definitely related to study treatment at any time from the infusion until day +28 post CAR-T infusion.
Measured: 28 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start16 Oct 2020
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- There will be two phases of this study. A dose escalation phase to determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Julie-An M. Talano, Medical College of Wisconsin
- Investigators
- Julie-An Talano, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049383
- Sponsor's protocol ID
- PRO00045861
- Acronym
- CAR-20/19-T
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2019
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Redirected Autologous T Cells Engineered to Contain an Anti-CD19 and Anti-CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed/ Refractory CD19 or CD20 B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04049383
- Acronym / sponsor ID
- CAR-20/19-T / PRO00045861
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, B-cell, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Aug 2019 (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.
This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.
Detailed description
This is a phase 1, interventional, open label, treatment study designed to evaluate the safety and feasibility of infusion of CAR-20/19-T in subjects with B cell ALL who have relapsed after prior therapies or refractory disease and are not candidates for curative intent standard therapy. There will be two phases of this study. First, a dose escalation phase will determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be two phases of this study. A dose escalation phase to determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level.
| Arm | Type | Receives |
|---|---|---|
| 5 x 10^5 CAR-20/19-T cells/kg | Experimental | Biological: CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. |
| 1 x10^6 CAR-20/19-T cells/kg | Experimental | Biological: CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. |
| 2.5 x10^6 CAR-20/19-T cells/kg | Experimental | Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. |
| Dose Expansion Phase | Experimental | Biological: CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg), Biological: CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg), Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg), Biological: CAR-20/19-T cellsThe study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Subjects will receive one of three dose levels. The dose expansion arm will be updated with the appropriate dose in the future based on the escalation results. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- Diagnosis of B-cell ALL: During the safety phase patients enrolled will be age ≥ 18 to age ≤ 70. Once those three patients have passed the 28-day waiting period post infusion, clearance from the FDA will be obtained to enroll pediatric patients. After FDA clearance -Patients must be aged ≥ 1 year and ≤ 70 years. All patients will have relapsed, refractory disease and no available curative options that meet clinical criteria to initiate treatment.
- Relapsed or refractory B cell ALL defined as one of the following:
- Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, or cytogenetics, or morphological disease in the bone marrow.
- Subjects with B-cell ALL must have either CD19 or CD20 positive disease on their most recent bone marrow performed. A minimum of 5% CD19 or CD20 positivity on prior biopsy or bone marrow aspiration (BMA) is required.
- Subjects with Ph+ ALL are eligible if they have relapsed or refractory disease and have failed at least two tyrosine kinase inhibitors.
Key exclusion criteria (20 listed)
- Positive beta-human chorionic gonadotropin (HCG) in female of childbearing potential.
- Subjects with known systemic allergy to bovine or murine products.
- Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy defined as >20 mg of prednisone.
- Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5 from any previous treatment unless it is felt to be due to underlying disease.
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 |
|---|---|---|
| CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level -1: 5 x 10^5 CAR-20/19-T cells/kg | Biological | 5 x 10^5 CAR-20/19-T cells/kg, Dose Expansion Phase |
| CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 0: 1 x10^6 CAR-20/19-T cells/kg (starting dose level) | Biological | 1 x10^6 CAR-20/19-T cells/kg, Dose Expansion Phase |
| CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 1: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose) | Biological | 2.5 x10^6 CAR-20/19-T cells/kg, Dose Expansion Phase |
| CAR-20/19-T cellsThe investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. The dose expansion dose level is still to be determined and this section will be updated. | Biological | Dose Expansion Phase |
Primary outcome
Number of Adverse Events after CAR 20/19-T Cell Infusion.
Time frame: 28 days after infusion
Adverse events will be measured and recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Occurrence of adverse events, defined as either CRS related Grade 3/4 toxicity or other NCI CTCAE version 5 non-hematologic ≥ grade 3 signs/symptoms, laboratory toxicities and clinical events that are possibly, probably or definitely related to study treatment at any time from the infusion until day +28 post CAR-T infusion.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Julie-An Talano, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg) and CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia With Failed Remission, run by Medical College of Wisconsin at 1 site 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 29 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events after CAR 20/19-T Cell Infusion. (time frame: 28 days after 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 12 Jan 2026.