B Cell MalignanciesPhase 1BaseCAR-01NCT07166549
Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)
A Phase 1 study testing Experimental Intervention in people with B Cell Malignancies and B-cell Leukemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Malignancies, B-cell Leukemia, B Cell Lymphoma
- What is being tested?
- Experimental Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2026to Nov 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:
- Acute B-lymphoblastic leukaemia
- Burkitt lymphoma
- Primary CNS lymphoma
- DLBCL or high-grade lymphoma of any subtype
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- Primary mediastinal B cell lymphoma (including grey zone lymphoma)
- Mantle Cell lymphoma
- Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma/leukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma
- CD19 and/or CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)
- ECOG clinical performance status ≤2
- Able to provide written informed consent.
- Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as:
- Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed)
- Adequate renal function: creatinine clearance ≥30 mL/min/1.73 m2
- Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation > 91% with room air.
- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia
- Adequate bone marrow reserve (Hemoglobin ≥80 g/L (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10^9/L (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10^9/L)
- Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy.
Who cannot join
- Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs
- Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.
- Uncontrolled coronary artery disease or uncontrolled arrhythmias
- Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.
- Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).
- Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer).
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- Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection.
- Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide
- Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG.
- Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.
- Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion.
- Investigational treatments within other trials ≤ 4 weeks before enrollment.
- Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jana van den Berg, Dr. med contact
Switzerland1 site
University Hospital Basel, Division of Hematology or Medical Oncology
Basel, Canton of Basel-City, 4031
Andreas Holbro, Prof. Dr., 0041 61 556 56 47, andreas.holbro@usb.ch
Andreas Holbro, Prof. Dr.
About this study
Official title: A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.
Read the detailed description
Chimeric antigen receptor (CAR) T cells are engineered T-lymphocytes with artificial receptors, containing domains of a T cell receptor as well as a B cell receptor with predefined specificity to a target antigen. In patients with relapsed or refractory (r/r) B-cell malignancies, who would otherwise have a poor prognosis, CD19-directed CAR T cell therapy showed high response rates. A common cause of relapse is loss of the target antigen on the tumor cells, e.g. CD19. In such cases, further approved treatment options are very limited to date, but recent preclinical and early clinical studies have shown that bispecific anti-CD19, anti-CD20 CAR T cells can overcome this hurdle, adding a second target and leading to excellent outcomes in heavily pretreated patients.
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options. A secondary objective is the assessment of efficacy.
- Conditions
- B Cell Malignancies, B-cell Leukemia, B Cell Lymphoma, Bispecific Chimeric Antigen Receptor (CAR) T Cells, Relapsed or Refractory (r/r) B-cell Malignancies
- Being tested
- Experimental Intervention
- Keywords
- Bispecific anti-CD19, anti-CD20 CAR T cell therapy, lymphapheresis, lymphodepleting (non- myeloablative) chemotherapy, Immune effector cell-associated neurotoxicity syndrome (ICANS), Cytokine release syndrome (CRS), Immune effector cell-associated haematotoxicity (ICAHT), European Group for Blood and Marrow Transplantation (EBMT), 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG), positron emission computed tomography (PET CT), acute lymphocytic leukemia (ALL), immunoglobulin heavy chain (IGH), non-Hodgkin's lymphoma (NHL), Eastern Cooperative Oncology Group (ECOG)
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell, Recurrence, Cytokine Release Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental InterventionDrug
The study intervention includes:
- Lymphapheresis
- Lymphodepleting chemotherapy
- CAR-T infusion
Lymphocytes will be collected from the patients by lymphapheresis to produce a personalized IMP, bispecific anti-CD19, anti-CD20 CAR T cells, which will be manufactured at the GMP facility of the University Hospital Basel.
Patients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2), before anti-CD19/20 CAR T cells are infused (day 0 = day of infusion).
Participants will undergo lymphapheresis 2-8 weeks prior to CAR T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention: Bispecific anti-CD19, anti-CD20 CAR T cells | Experimental | Bispecific anti-CD19, anti-CD20 CAR T cells administration Receives: Drug: Experimental Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Adverse Events
All adverse events will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the CTCAE Version v5.0.
Measured: up to 3 months after CAR T cell infusion
Evaluation of Adverse Events of special interest (CRS)
All adverse events of special interest (CRS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the ASTCT CRS Consensus Grading (Grade 1 up to Grade 4; with Grade 4 as most severe CRS Grade)
Measured: up to 3 months after CAR T cell infusion
Evaluation of Adverse Events of special interest (ICANS)
All adverse events of special interest (ICANS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the Immune-effector Cell-associated Encephalopathy (ICE) test, which was developed to provide objectivity for screening and grading the severity of ICANS. The ICE score is performed at least every 8 hours during in-patient care and at every outpatient visit. A higher score indicates better cognitive function, with a perfect score of 10 signifying no impairment.
Measured: up to 3 months after CAR T cell infusion
Evaluation of Adverse Events of special interest (ICAHT)
Evaluation of Adverse Events of special interest (ICAHT) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the EHA/EBMT consensus grading. The EHA/EBMT consensus grading score is a classification system based on depth and duration of neutropenia.
Measured: up to 3 months after CAR T cell infusion
Secondary outcomes (8)
Objective response rate (ORR): Change in metabolic response in FDG-PET/CT scan
For lymphomas and B-cell ALL with lymphadenopathy metabolic response in FDG-PET/CT scan according to the Lugano Classification (Response assessment: Complete Remission; Partial Remission; Progressive Disease)
Measured: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in blood
For patients with B-cell ALL minimal residual disease (MRD) negativity as determined by flow cytometry
Measured: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in bone marrow
For patients with B-cell ALL minimal residual disease (MRD) negativity as determined by flow cytometry
Measured: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in sustained MRD-negative Complete Remission (CR)
For patients with B-cell ALL: Sustained MRD-negative CR determined by polymerase chain reaction of the IgH rearrangement
Measured: 1, 3, 6 and 12 months after CAR T cell infusion
Progression-free survival
Progression-free survival, defined as the time between infusion of CAR T product to progression or death, whichever occurs first
Measured: up to 12 months after CAR T cell infusion
Event free survival
Event free survival, defined as time between infusion of CAR T product to not achieving complete remission 3 months after CAR T infusion, progression, or death, whichever occurs first.
Measured: up to 3 months after CAR T cell infusion
Overall survival
Overall survival, defined as the time between the day of infusion of CAR T product to death of any cause.
Measured: up to 12 months after CAR T cell infusion
Cumulative incidence of non-relapse mortality
Cumulative incidence of non-relapse mortality, defined as any death not related to underlying lymphoid malignancy.
Measured: up to 12 months after 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 posted10 Sep 2025
- Study startJun 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Holbro, Prof. Dr., Principal investigator, University Hospital Basel, Division of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166549
- Sponsor's protocol ID
- 2025-01562, th23Holbro
- Other IDs
- 2025
- Acronym
- BaseCAR-01
- Status last verified
- Dec 2025
- First submitted
- 3 Sep 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Bispecific Anti-CD19, Anti-CD20 CAR T Cells for B Cell Malignancies
- ClinicalTrials.gov ID
- NCT07166549
- Acronym / sponsor ID
- BaseCAR-01 / 2025-01562, th23Holbro
- Conditions
- B Cell Malignancies, B-cell Leukemia, B Cell Lymphoma, Bispecific Chimeric Antigen Receptor (CAR) T Cells, Relapsed or Refractory (r/r) B-cell Malignancies
- Keywords
- Bispecific anti-CD19, anti-CD20 CAR T cell therapy, lymphapheresis, lymphodepleting (non- myeloablative) chemotherapy, Immune effector cell-associated neurotoxicity syndrome (ICANS), Cytokine release syndrome (CRS), Immune effector cell-associated haematotoxicity (ICAHT), European Group for Blood and Marrow Transplantation (EBMT), 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Sep 2025 (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 study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options.
Detailed description
Chimeric antigen receptor (CAR) T cells are engineered T-lymphocytes with artificial receptors, containing domains of a T cell receptor as well as a B cell receptor with predefined specificity to a target antigen. In patients with relapsed or refractory (r/r) B-cell malignancies, who would otherwise have a poor prognosis, CD19-directed CAR T cell therapy showed high response rates. A common cause of relapse is loss of the target antigen on the tumor cells, e.g. CD19. In such cases, further approved treatment options are very limited to date, but recent preclinical and early clinical studies have shown that bispecific anti-CD19, anti-CD20 CAR T cells can overcome this hurdle, adding a second target and leading to excellent outcomes in heavily pretreated patients.
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter. The primary objective is to assess the safety of bispecific anti-CD19, anti- CD20 CAR T cell-therapies after lymphodepleting chemotherapy in patients with B cell malignancies with exhausted standard treatment options. A secondary objective is the assessment of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention: Bispecific anti-CD19, anti-CD20 CAR T cells | Experimental | Drug: Experimental InterventionBispecific anti-CD19, anti-CD20 CAR T cells administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years
- Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including:
- CD19 and/or CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry)
- ECOG clinical performance status ≤2
- Able to provide written informed consent.
Key exclusion criteria (14 listed)
- Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs
- Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease.
- Uncontrolled coronary artery disease or uncontrolled arrhythmias
- Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status.
- Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma).
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 |
|---|---|---|
| Experimental InterventionThe study intervention includes: * Lymphapheresis * Lymphodepleting chemotherapy * CAR-T infusion Lymphocytes will be collected from the patients by lymphapheresis to produce a personalized IMP, bispecific anti-CD19, anti-CD20 CAR T cells, which will be manufactured at the GMP facility of the University Hospital Basel. Patients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2), before anti-CD19/20 CAR T cells are infused (day 0 = day of infusion). Participants will undergo lymphapheresis 2-8 weeks prior to CAR T cell infusion. | Drug | Experimental Intervention: Bispecific anti-CD19, anti-CD20 CAR T cells |
Primary outcome
Evaluation of Adverse Events
Time frame: up to 3 months after CAR T cell infusion
All adverse events will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the CTCAE Version v5.0.
Evaluation of Adverse Events of special interest (CRS)
Time frame: up to 3 months after CAR T cell infusion
All adverse events of special interest (CRS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the ASTCT CRS Consensus Grading (Grade 1 up to Grade 4; with Grade 4 as most severe CRS Grade)
Evaluation of Adverse Events of special interest (ICANS)
Time frame: up to 3 months after CAR T cell infusion
All adverse events of special interest (ICANS) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the Immune-effector Cell-associated Encephalopathy (ICE) test, which was developed to provide objectivity for screening and grading the severity of ICANS. The ICE score is performed at least every 8 hours during in-patient care and at every outpatient visit. A higher score indicates better cognitive function, with a perfect score of 10 signifying no impairment.
Evaluation of Adverse Events of special interest (ICAHT)
Time frame: up to 3 months after CAR T cell infusion
Evaluation of Adverse Events of special interest (ICAHT) will be assessed in a structured manner (time of onset, duration, resolution, action been taken, assessment of intensity, relationship with study treatment), using the EHA/EBMT consensus grading. The EHA/EBMT consensus grading score is a classification system based on depth and duration of neutropenia.
8 secondary outcomes
Objective response rate (ORR): Change in metabolic response in FDG-PET/CT scan
Time frame: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in blood
Time frame: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in minimal residual disease (MRD) negativity in bone marrow
Time frame: 1, 3, 6 and 12 months after CAR T cell infusion
Objective response rate (ORR): Change in sustained MRD-negative Complete Remission (CR)
Time frame: 1, 3, 6 and 12 months after CAR T cell infusion
Progression-free survival
Time frame: up to 12 months after CAR T cell infusion
Event free survival
Time frame: up to 3 months after CAR T cell infusion
Overall survival
Time frame: up to 12 months after CAR T cell infusion
Cumulative incidence of non-relapse mortality
Time frame: up to 12 months after CAR T cell infusion
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 24 Dec 2025.
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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.
Jana van den Berg, Dr. med contact
Andreas Holbro, Prof. Dr. principal investigator
University Hospital Basel, Division of Hematology
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 Experimental Intervention in people with B Cell Malignancies and B-cell Leukemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 19 inclusion and 14 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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 Switzerland. 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 Andreas Holbro, Prof. Dr. (+41 61 556 56 47, andreas.holbro@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Adverse Events (time frame: up to 3 months after CAR T cell infusion). The study lists 4 primary outcomes in all. 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 24 Dec 2025.