B-Cell LymphomaPhase 1NCT07168486
CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas
A Phase 1 study testing CD19.20.22 CAR T cells and Fludarabine and Cyclophosphamide in people with B-Cell Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- What is being tested?
- CD19.20.22 CAR T cells and Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 1 Jul 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
- Histologically confirmed relapsed/refractory B cell Lymphoma. Histologies allowed: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), Follicular Lymphoma (FL), transformed follicular lymphoma (tFL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Richter's transformation with or without concurrent CLL, Burkitt's lymphoma.
- Relapsed or Refractory disease after two lines or more of therapy (except one or more line for MCL) including rituximab and other anti-CD20 antibodies, BTK inhibitors (Mantle Cell Lymphoma only), and anthracycline (specifically for DLBCL, PMBCL, tFL, and Burkitt's lymphoma).
- Measurable disease according to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma [2]. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 1.5 cm.
- Two out of three target antigen expression required (IHC or flow per institutional guidelines) on the most recent biopsy available. We will analyze a tumor sample from the most recent relapse or development of refractory disease state (archival sample within <6 months) for antigen expression. Alternatively, a new biopsy will be obtained in case archival material is not available.
- Prior Auto CAR T permitted (washout 3 months)
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- Prior ASCT is permitted and prior AlloSCT is permitted if off immunosuppression and no clinically significant (more than grade 1) GVHD
- Prior Allo CAR T permitted (washout 1 month, permitting hematologic parameters)
- Prior Bispecific T-Cell Engager (BiTE) permitted (washout 3 months)
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint (ICP) therapy and anti-CD20 mAb therapy
- At least 3 half-lives must have elapsed after any prior systemic inhibitory/stimulatory ICP or anti-CD20 mAb therapy at the time the subject is planned for leukapheresis
- ECOG 0 or 1
- Acceptable Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion) Cardiac ejection fraction (EF) greater than or equal to 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA) Resting O2 saturation >90% on room air Total bilirubin ≤ 1.5 mg/dL except in individuals with Gilbert's syndrome Total bilirubin ≤ 3.0 mg/dL in individuals with Gilbert's syndrome Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) <5 times the Upper Limit of Normal (ULN) for age
- A creatinine clearance (as estimated by direct urine collection or the non-racial CKD-EPI equation) > 30 mL/min
- Subjects must have the following hematologic function parameters:
- Absolute neutrophil count (ANC) > 1000/µL Absolute Lymphocyte Count > 100/µL Platelets > 50,000/µL
- Estimated life expectancy of more than 3 months independent from primary disease
- Subjects of child-bearing or child-fathering potential must be willing to use study-defined highly-effective methods birth control from the time of enrollment on this study through the study follow-up period Study-defined highly-effective methods of birth control are implants, levonorgestrel releasing intrauterine systems, medroxyprogesterone acetate depot, tubal sterilization, sexual intercourse with a vasectomised male partner only (vasectomy must be confirmed by two negative semen analyses), and ovulation inhibitory progesterone.
Who cannot join
- Unable to give informed consent
- Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), If there is a history of treated hepatitis B or hepatitis C, the viral load must be polymerase chain reaction (PCR) negative; antiviral secondary prophylaxis is required if HBsAg negative and anti-HBc positive
- Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and/or nucleic acid testing
- Known history of active seizure or presence of seizure activities or on active anti-seizure medications within the prior 12 months
- Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease
- Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity
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- Active systemic fungal, viral or bacterial infection
- Pregnant or breast-feeding woman
- Previous or concurrent malignancy with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study Adequately treated breast or prostate carcinoma on hormonal maintenance therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years A primary malignancy which has been completely resected / treated with curative intent and in complete remission of ≥ 2 years History of non-neurologic autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive or systemic disease modifying agents (equivalent to > 10 mg prednisone daily) within the last 2 years
- Medical condition requiring prolonged use of systemic corticosteroids equivalent to Prednisone >10 mg/day
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
- Concurrent radiotherapy (normal tissue sparing palliative radiotherapy allowed up to time of lymphodepletion).
- For systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.
- Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Clinical suspicion of central nervous system (CNS) lymphoma
- If the subject has history of CNS disease, then he/she must Have no signs or symptoms of active CNS disease Have no active disease on magnetic resonance imaging (MRI)- e.g. vasogenic edema; stable, post-treatment changes are acceptable.
- Have no malignant cells of any type present in cerebrospinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of number of white blood cells (WBCs)
- In case of cerebral vascular accident (CVA) The CVA event must be > 12 months prior to leukapheresis Any neurological deficits must be stable
- ECOG 2 or higher (unless due to lymphoma diagnosis)
- Ongoing immunosuppression for graft versus host disease treatment or prophylaxis (prior allogeneic stem cell transplant permitted)
- History of a severe hypersensitivity reaction or contraindication to any of the agents used in the study (including fludarabine and cyclophosphamide).
- Subjects of both genders who are not willing to practice highly effective birth control from the time of informed consent through 6 months after the CAR19.20.22infusion
- In the investigator's judgment, the subject is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: A Phase Ia Study of Tri-specific CAR19.20.22 Chimeric Antigen Receptor (CAR) T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas
The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells.
Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show:
- good safety and tolerability
- a high degree of efficacy
- very good persistence
- an acceptable level of exhaustion
Read the detailed description
This is a phase 1a, open-label, single center study evaluating the safety and efficacy CAR19.20.22 in subjects with r/r B-cell malignancies. The study will comprise dose-escalation.
The dose-escalation will use a modified 3+3 design. Up to 12 subjects will be enrolled and treated at the sequential dose-escalation levels and evaluated. Infusion of CAR19.20.22 will be staggered to allow observations of acute and subacute toxicities.
- Conditions
- B-Cell Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Follicular Lymphoma, Transformed Follicular Lymphoma (tFL), Mantle Cell Lymphoma
- Being tested
- CD19.20.22 CAR T cells, Fludarabine and Cyclophosphamide
- Keywords
- relapsed, refractory, B-Cell Malignancies, Car T-cells, Lymphodepletion
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19.20.22 CAR T cellsBiological
CAR19.20.22 is a type of immunotherapy known as a chimeric antigen receptor T-cells (CAR T-cells).
Fludarabine and CyclophosphamideDrug
Lymphodepletion with Flu-Cy prior to CAR T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Dose Level -1 | Experimental | Autologous CAR19.20.22 T-cells, 0.75 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. Receives: Biological: CD19.20.22 CAR T cells; Drug: Fludarabine and Cyclophosphamide |
| Dose Level 0 | Experimental | Autologous CAR19.20.22 T-cells, 1.0 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. Receives: Biological: CD19.20.22 CAR T cells; Drug: Fludarabine and Cyclophosphamide |
| Dose Level 1 | Experimental | Autologous CAR19.20.22 T-cells, 2.5 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. Receives: Biological: CD19.20.22 CAR T cells; Drug: Fludarabine and Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability]
To evaluate the safety and tolerability of CAR19.20.22 CAR T-cells
Measured: From date of enrollment assessed up to 24 months
Efficacy Overall Response Rate in participants
Effect on the disease: Number of patients with clinical responses: Overall Survival (OS); Progression-Free Survival (PFS); Overall Response Rate (ORR)
Measured: From date of enrollment assessed up to 24 months
Change in CAR19.20.22 T-cell function assessed by multicolor ELISPOT assay using CD19/CD22 protein targets.
Function will be assessed using in-house multicolor ELISPOT assays performed on leukapheresis product, starting T-cells, final CAR T-cell product, and post-infusion blood samples.
To evaluate the functionality of the CAR T-cells over time using our in-house developed multicolor enzyme-linked immune absorbent spot (ELISPOT) assays using beads covered with CD19 and CD22 recombinant proteins as targets.
Measured: From date of enrollment assessed up to 24 months
Persistence of CAR19.20.22 T-cells in peripheral blood measured by qPCR vector copy number and flow cytometry enumeration of CD19 and CD22 CAR-expressing T-cells."
PK/PD persistence will be evaluated using qPCR to quantify vector copy number and flow cytometry to enumerate CD19 and CD22 CAR-expressing T-cells.
Pharmacokinetics/Pharmacodynamics (PK/PD) - In vivo duoCAR T-cell persistence in peripheral blood samples by qPCR to measure vector copy number or Flow Cytometry to enumerate CD19 CAR or CD22 CAR expressing T-cells.
Measured: From date of enrollment assessed up to 24 months
Secondary outcomes (5)
Incidence of antibodies to CAR19.20.22 T-cells
Incidence of antibodies to CAR19.20.22 measured in serum samples (up to 24 months).
Serum samples will be tested for anti-CAR antibody responses.
Measured: Up to 24 months
Cytokine levels in plasma post-infusion
Cytokines such as IL-6 and IFN-γ will be measured by multiplex immunoassays.
Measured: Up to 24 months
Persistence of CAR19.20.22 T-cells
Enumeration of CAR T-cells from blood samples using flow cytometry.
Measured: Up to 24 months
Phenotype of CAR19.20.22 T-cells
Phenotypic analysis of CAR T-cells from blood samples using flow cytometry.
Measured: Up to 24 months
Number of CAR19.20.22 T-cell products manufactured that meet release criteria at Day 8
Feasibility will be assessed by counting the number of autologous CAR T-cell products that successfully meet pre-specified release criteria at Day 8 of manufacturing.
Measured: At day 8 of manufacturing post-leukapheresis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start28 Oct 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 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 LymphomaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djordje Atanackovic, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168486
- Sponsor's protocol ID
- 2372GCCC; HP-00107536
- Status last verified
- Sep 2026
- First submitted
- 13 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Study of Tri-specific CAR19.20.22 Chimeric Antigen Receptor (CAR) T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT07168486
- Acronym / sponsor ID
- 2372GCCC; HP-00107536
- Conditions
- B-Cell Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Follicular Lymphoma, Transformed Follicular Lymphoma (tFL), Mantle Cell Lymphoma
- Keywords
- relapsed, refractory, B-Cell Malignancies, Car T-cells, Lymphodepletion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 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.
The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells.
Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show:
- good safety and tolerability
- a high degree of efficacy
- very good persistence
- an acceptable level of exhaustion
Detailed description
This is a phase 1a, open-label, single center study evaluating the safety and efficacy CAR19.20.22 in subjects with r/r B-cell malignancies. The study will comprise dose-escalation.
The dose-escalation will use a modified 3+3 design. Up to 12 subjects will be enrolled and treated at the sequential dose-escalation levels and evaluated. Infusion of CAR19.20.22 will be staggered to allow observations of acute and subacute toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level -1 | Experimental | Biological: CD19.20.22 CAR T cells, Drug: Fludarabine and CyclophosphamideAutologous CAR19.20.22 T-cells, 0.75 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. |
| Dose Level 0 | Experimental | Biological: CD19.20.22 CAR T cells, Drug: Fludarabine and CyclophosphamideAutologous CAR19.20.22 T-cells, 1.0 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. |
| Dose Level 1 | Experimental | Biological: CD19.20.22 CAR T cells, Drug: Fludarabine and CyclophosphamideAutologous CAR19.20.22 T-cells, 2.5 × 10^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years
- Histologically confirmed relapsed/refractory B cell Lymphoma. Histologies allowed: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), Follicular Lymphoma (FL), transformed follicular lymphoma (tFL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Richter's transformation with or without concurrent CLL, Burkitt's lymphoma.
- Relapsed or Refractory disease after two lines or more of therapy (except one or more line for MCL) including rituximab and other anti-CD20 antibodies, BTK inhibitors (Mantle Cell Lymphoma only), and anthracycline (specifically for DLBCL, PMBCL, tFL, and Burkitt's lymphoma).
- Measurable disease according to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma [2]. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 1.5 cm.
- Two out of three target antigen expression required (IHC or flow per institutional guidelines) on the most recent biopsy available. We will analyze a tumor sample from the most recent relapse or development of refractory disease state (archival sample within <6 months) for antigen expression. Alternatively, a new biopsy will be obtained in case archival material is not available.
Key exclusion criteria (25 listed)
- Unable to give informed consent
- Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), If there is a history of treated hepatitis B or hepatitis C, the viral load must be polymerase chain reaction (PCR) negative; antiviral secondary prophylaxis is required if HBsAg negative and anti-HBc positive
- Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and/or nucleic acid testing
- Known history of active seizure or presence of seizure activities or on active anti-seizure medications within the prior 12 months
- Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory 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 |
|---|---|---|
| CD19.20.22 CAR T cellsCAR19.20.22 is a type of immunotherapy known as a chimeric antigen receptor T-cells (CAR T-cells). | Biological | Dose Level -1, Dose Level 0, Dose Level 1 |
| Fludarabine and CyclophosphamideLymphodepletion with Flu-Cy prior to CAR T cell therapy | Drug | Dose Level -1, Dose Level 0, Dose Level 1 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability]
Time frame: From date of enrollment assessed up to 24 months
To evaluate the safety and tolerability of CAR19.20.22 CAR T-cells
Efficacy Overall Response Rate in participants
Time frame: From date of enrollment assessed up to 24 months
Effect on the disease: Number of patients with clinical responses: Overall Survival (OS); Progression-Free Survival (PFS); Overall Response Rate (ORR)
Change in CAR19.20.22 T-cell function assessed by multicolor ELISPOT assay using CD19/CD22 protein targets.
Time frame: From date of enrollment assessed up to 24 months
Function will be assessed using in-house multicolor ELISPOT assays performed on leukapheresis product, starting T-cells, final CAR T-cell product, and post-infusion blood samples. To evaluate the functionality of the CAR T-cells over time using our in-house developed multicolor enzyme-linked immune absorbent spot (ELISPOT) assays using beads covered with CD19 and CD22 recombinant proteins as targets.
Persistence of CAR19.20.22 T-cells in peripheral blood measured by qPCR vector copy number and flow cytometry enumeration of CD19 and CD22 CAR-expressing T-cells."
Time frame: From date of enrollment assessed up to 24 months
PK/PD persistence will be evaluated using qPCR to quantify vector copy number and flow cytometry to enumerate CD19 and CD22 CAR-expressing T-cells. Pharmacokinetics/Pharmacodynamics (PK/PD) - In vivo duoCAR T-cell persistence in peripheral blood samples by qPCR to measure vector copy number or Flow Cytometry to enumerate CD19 CAR or CD22 CAR expressing T-cells.
5 secondary outcomes
Incidence of antibodies to CAR19.20.22 T-cells
Time frame: Up to 24 months
Cytokine levels in plasma post-infusion
Time frame: Up to 24 months
Persistence of CAR19.20.22 T-cells
Time frame: Up to 24 months
Phenotype of CAR19.20.22 T-cells
Time frame: Up to 24 months
Number of CAR19.20.22 T-cell products manufactured that meet release criteria at Day 8
Time frame: At day 8 of manufacturing post-leukapheresis.
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 14 Sep 2026.
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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.
Djordje Atanackovic, MD principal investigator
Professor of Medicine
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 CD19.20.22 CAR T cells and Fludarabine and Cyclophosphamide in people with B-Cell Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), run by University of Maryland, Baltimore 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 18 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: enrolling by invitation, as of the sponsor's last update on 14 Sep 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?
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?
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 participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability] (time frame: From date of enrollment assessed up to 24 months). 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 14 Sep 2026.