Acute Lymphoblastic Leukemia, in RelapsePhase 1/2NCT03573700
Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and Mesna in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia, Refractory
- What is being tested?
- Cyclophosphamide, Fludarabine and Mesna
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 1 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- CD19+ ALL with any of the following:
- Minimal Residual Disease (MRD) ≥ 1% at end of up-front induction therapy
- Hypodiploid (< 44 chromosomes or < 0.95 DNA index) CD19+ ALL with detectable disease at the end of up-front induction therapy
- Increase in disease burden any time after the completion of up-front induction therapy
- Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission
Show all 43Show fewer
- Refractory disease despite salvage therapy
- 1st or greater relapse
- Estimated life expectancy of > 12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥ 50
- Patients with a history of prior allogeneic hematopoietic cell transplantation [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
- 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
- CD19+ ALL with any of the following:
- Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission
- Refractory disease despite salvage therapy
- 2nd or greater relapse
- Any relapse after allogeneic hematopoietic cell transplantation
- 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT for any of the following reasons:
- Patients that do not have an available allogeneic donor (defined as at least a 7/8 HLA-matched related/unrelated donor, 5/6 HLA-matched umbilical cord donor, or 3/6 HLA-matched haploidentical donor)
- Patients with refractory leukemia, for which allogeneic transplant is known to be less effective in the B-ALL population, and
- Patients who are unable to receive myeloablative total body irradiation (TBI), which is included in standard transplant regimens for patients with B - ALL.
- Detectable disease
- Age: ≤ 21 years of age
- Estimated life expectancy of > 8 weeks
- Prior to planned SJCAR19 infusion, patients with a history of prior allogeneic HCT must be at least 3 months from HCT, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion
- 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
- Karnofsky or Lansky (age-dependent) performance score ≥ 50
- 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
- Hemoglobin > 8 g/dl (can be transfused)
- Platelet count > 20,000/μL (can be transfused)
- 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 6 months after T-cell infusion. Male partners should use a condom
- Available SJCAR19 product with ≥ 15% expression of the CD19-CAR, and killing of CD19+ targets ≥ 20% in an in vitro cytotoxicity assay
- Agreement to participate in long-term follow-up on protocol NCT00695279
Who cannot join
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Eligibility Criteria for Manufacturing SJCAR19:
- CD19+ ALL with any of the following:
Show all 25Show fewer
- Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission
- Refractory disease despite salvage therapy
- 2nd or greater relapse
- Any relapse after allogeneic hematopoietic cell transplantation
- 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT
- Age: ≤ 21 years of age
- Karnofsky or Lansky (age-dependent) performance score ≥ 50
- Estimated life expectancy of > 12 weeks
- Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
- CNS-3 disease with or without neurologic changes
- CNS-1/CNS-2 disease with neurologic changes
- Known primary immunodeficiency
- History of HIV infection
- Evidence of active, uncontrolled neurologic disease
- Severe, uncontrolled bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/ kg/day of methylprednisolone, in the 7 days prior to CAR T-cell infusion
- Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusion
- Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: SJCAR19: A Phase I/II Study Evaluating SJCAR19 (CD19-Specific CAR Engineered Autologous T-Cells) in Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of the body's basic disease fighters: antibodies and T Cells. For this type of therapy, peripheral (circulating) immune cells are collected and then undergo a manufacturing process to engineer them to more effectively kill cancer cells. The SJCAR19 product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility.
The main purpose of this study is to determine:
- The largest dose of SJCAR19 that is safe to give,
- How long SJCAR19 cells last in the body,
- The side effects of SJCAR19, and
- Whether or not treatment with SJCAR19 is effective in treating people with refractory or relapsed ALL.
Read the detailed description
SJCAR19 is a Phase I/II clinical trial evaluating the use of SJCAR19 (CD19- specific CAR engineered autologous T-cells) in pediatric, adolescent and young adult patients with relapsed/ refractory CD19+ ALL. Treatment will include a single treatment course, with most patients receiving a lymphodepleting chemotherapy preparative regimen of fludarabine/ cyclophosphamide, followed by a single infusion of SJCAR19.
This protocol contains a 3-part consent process: 1) to proceed with autologous apheresis, 2) to proceed with manufacturing of the SJCAR19 product, and 3) to receive treatment with the SJCAR19 product (initially as Phase I, then proceeding to Phase II). The Phase I portion will evaluate the safety and maximum tolerated dose (MTD) of SJCAR19.
The Phase II portion will evaluate the efficacy, and provide further safety evaluation, of SJCAR19 in an expansion cohort at the MTD determined in the Phase I portion of the study. Additionally, for both the Phase I/II portions of the study there are correlative studies evaluating the biology of this treatment as well assessments into patient/caregiver experiences with undergoing this treatment.
- Being tested
- Cyclophosphamide, Fludarabine, Mesna, CliniMACS, CD19- specific CAR engineered autologous T-cells (SJCAR19 product)
- Keywords
- Leukemia, Leukemia, lymphoid, Leukemia, B-cell, Relapsed, Refractory, Pediatric, Chimeric antigen receptor, CAR, CAR T cell, Anti-CD19, CD19
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Leukemia, Lymphoid, Leukemia, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan
Given IV
FludarabineDrug
Also called Fludara
Given IV
MesnaDrug
Also called Mesnex
Given IV
CliniMACSDevice
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.
CD19- specific CAR engineered autologous T-cells (SJCAR19 product)Biological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| SJCAR19 Therapy | Experimental | Patients in both the Phase I and Phase II portion of the study will receive lymphodepleting chemotherapy (unless determined by PI that lymphodepletion is not necessary), followed by a single infusion of the patient-derived SJCAR19 cellular product. The most commonly used lymphodepleting chemotherapy regimen will consist of the agents: Fludarabine and Cyclophosphamide. They will also receive Mesna. Dosing of SJCAR19 on the Phase I study will follow a dose escalation schema, with dose changes based on dose-limiting toxicities. In the Phase II study, SJCAR19 dosing with follow the maximum tolerated dose, as determined in the Phase I portion.
Cells for infusion are prepared using the CliniMACS System. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Device: CliniMACS; Biological: CD19- specific CAR engineered autologous T-cells (SJCAR19 product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose and Dose-limiting Toxicities
The primary objectives for the Phase I study portion are to determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with SJCAR19 in pediatric and young adult patient's ≤ 21 years of age, with relapsed or refractory CD19+ ALL. The proportion of participants with dose limiting toxicities are reported.
Measured: 4 weeks post-SJCAR19 infusion
Complete Response Rate
The primary objective for the Phase II study portion is to evaluate the complete response (CR) rates of SJCAR19 in pediatric and young adult patient's ≤ 21 years of age, with relapsed or refractory CD19+ ALL.
Measured: 4 weeks post-SJCAR19 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start24 Jul 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee C. Talleur, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573700
- Sponsor's protocol ID
- SJCAR19
- Other IDs
- NCI-2017-01399
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2018
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Talleur AC, Qudeimat A, Metais JY, Langfitt D, Mamcarz E, Crawford JC, Huang S, Cheng C, Hurley C, Madden R, Sharma A, Suliman A, Srinivasan A, Velasquez MP, Obeng EA, Willis C, Akel S, Karol SE, Inaba H, Bragg A, Zheng W, Zhou SM, Schell S, Tuggle-Brown M, Cullins D, Patil SL, Li Y, Thomas PG, Zebley C, Youngblood B, Pui CH, Lockey T, Geiger TL, Meagher MM, Triplett BM, Gottschalk S. Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL. Blood Adv. 2022 Nov 8;6(21):5737-5749. doi: 10.1182/bloodadvances.2021006293.
PubMed 35446934
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SJCAR19: A Phase I/II Study Evaluating SJCAR19 (CD19-Specific CAR Engineered Autologous T-Cells) in Pediatric and Young Adult Patients ≤ 21 Years of Age With Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03573700
- Acronym / sponsor ID
- SJCAR19
- Keywords
- Leukemia, Leukemia, lymphoid, Leukemia, B-cell, Relapsed, Refractory, Pediatric, Chimeric antigen receptor, CAR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of the body's basic disease fighters: antibodies and T Cells. For this type of therapy, peripheral (circulating) immune cells are collected and then undergo a manufacturing process to engineer them to more effectively kill cancer cells. The SJCAR19 product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility.
The main purpose of this study is to determine:
- The largest dose of SJCAR19 that is safe to give,
- How long SJCAR19 cells last in the body,
- The side effects of SJCAR19, and
- Whether or not treatment with SJCAR19 is effective in treating people with refractory or relapsed ALL.
Detailed description
SJCAR19 is a Phase I/II clinical trial evaluating the use of SJCAR19 (CD19- specific CAR engineered autologous T-cells) in pediatric, adolescent and young adult patients with relapsed/ refractory CD19+ ALL. Treatment will include a single treatment course, with most patients receiving a lymphodepleting chemotherapy preparative regimen of fludarabine/ cyclophosphamide, followed by a single infusion of SJCAR19.
This protocol contains a 3-part consent process: 1) to proceed with autologous apheresis, 2) to proceed with manufacturing of the SJCAR19 product, and 3) to receive treatment with the SJCAR19 product (initially as Phase I, then proceeding to Phase II). The Phase I portion will evaluate the safety and maximum tolerated dose (MTD) of SJCAR19.
The Phase II portion will evaluate the efficacy, and provide further safety evaluation, of SJCAR19 in an expansion cohort at the MTD determined in the Phase I portion of the study. Additionally, for both the Phase I/II portions of the study there are correlative studies evaluating the biology of this treatment as well assessments into patient/caregiver experiences with undergoing this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SJCAR19 Therapy | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Mesna, Device: CliniMACS, Biological: CD19- specific CAR engineered autologous T-cells (SJCAR19 product)Patients in both the Phase I and Phase II portion of the study will receive lymphodepleting chemotherapy (unless determined by PI that lymphodepletion is not necessary), followed by a single infusion of the patient-derived SJCAR19 cellular product. The most commonly used lymphodepleting chemotherapy regimen will consist of the agents: Fludarabine and Cyclophosphamide. They will also receive Mesna. Dosing of SJCAR19 on the Phase I study will follow a dose escalation schema, with dose changes based on dose-limiting toxicities. In the Phase II study, SJCAR19 dosing with follow the maximum tolerated dose, as determined in the Phase I portion. Cells for infusion are prepared using the CliniMACS System. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (43 listed)
- Age ≤ 21 years old
- CD19+ ALL with any of the following:
- Estimated life expectancy of > 12 weeks
- Karnofsky or Lansky (age-dependent) performance score ≥ 50
- Patients with a history of prior allogeneic hematopoietic cell transplantation [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
Key exclusion criteria (25 listed)
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- CD19+ ALL with any of the following:
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 |
|---|---|---|
| CyclophosphamideAlso: CytoxanGiven IV | Drug | SJCAR19 Therapy |
| FludarabineAlso: FludaraGiven IV | Drug | SJCAR19 Therapy |
| MesnaAlso: MesnexGiven IV | Drug | SJCAR19 Therapy |
| CliniMACSThe mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest. | Device | SJCAR19 Therapy |
| CD19- specific CAR engineered autologous T-cells (SJCAR19 product)Given IV | Biological | SJCAR19 Therapy |
Primary outcome
Maximum Tolerated Dose and Dose-limiting Toxicities
Time frame: 4 weeks post-SJCAR19 infusion
The primary objectives for the Phase I study portion are to determine the maximum tolerated dose (MTD) and characterize the safety profile and dose-limiting toxicities (DLTs) of treatment with SJCAR19 in pediatric and young adult patient's ≤ 21 years of age, with relapsed or refractory CD19+ ALL. The proportion of participants with dose limiting toxicities are reported.
Complete Response Rate
Time frame: 4 weeks post-SJCAR19 infusion
The primary objective for the Phase II study portion is to evaluate the complete response (CR) rates of SJCAR19 in pediatric and young adult patient's ≤ 21 years of age, with relapsed or refractory CD19+ ALL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35446934Talleur AC, Qudeimat A, Metais JY, Langfitt D, Mamcarz E, Crawford JC, Huang S, Cheng C, Hurley C, Madden R, Sharma A, Suliman A, Srinivasan A, Velasquez MP, Obeng EA, Willis C, Akel S, Karol SE, Inaba H, Bragg A, Zheng W, Zhou SM, Schell S, Tuggle-Brown M, Cullins D, Patil SL, Li Y, Thomas PG, Zebley C, Youngblood B, Pui CH, Lockey T, Geiger TL, Meagher MM, Triplett BM, Gottschalk S. Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL. Blood Adv. 2022 Nov 8;6(21):5737-5749. doi: 10.1182/bloodadvances.2021006293.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Acute Lymphoblastic Leukemia, in Relapse
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
Not yet recruitingPhase 2
Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia, Adult
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.
Aimee C. Talleur, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and Mesna in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia, Refractory, run by St. Jude Children's Research Hospital 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 43 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose and Dose-limiting Toxicities (time frame: 4 weeks post-SJCAR19 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573700, which also lists 1 linked publication.
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 11 Aug 2026.