Non Hodgkin LymphomaPhase 1NCT04732845
Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study testing Fully human anti CD19 CAR-T Cell Dose, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia, run by Benjamin Tomlinson at 1 site in United States.
Trial summary
The purpose of this study is to determine if it is possible to treat relapsed or refractory lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the immune system to treat the cancer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia
- What is being tested?
- Fully human anti CD19 CAR-T Cell Dose, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 1 Dec 2040
- 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
- Must have relapsed or refractory non-Hodgkin lymphoma (NHL) (Group A - NHL/CLL), chronic lymphocytic leukemia (Group A - NHL/CLL) or acute lymphoblastic leukemia (Group B - ALL) treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.
- The participant's malignancy is CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
- Total bilirubin ≤ 1.5 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 time normal) or of non-hepatic origin
- AST (SGOT) ≤ 3 times institutional upper limit of normal
- ALT (SGPT) ≤ 3 times institutional upper limit of normal
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- Serum Creatinine ≤ 2 times the institutional upper limit of normal and creatinine clearance ≥ 30 mL/min (calculated or measured)
- Must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
- Must have adequate cardiac function as defined as left ventricular ejection fraction≥ 40% in the most recent echocardiogram.
- Absolute Lymphocyte Count >100/microliter (uL)
- Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the human anti-CD19 CAR-T cell infusion. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the human anti-CD19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the human antiCD19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods
Who cannot join
- Autologous transplant within 6 weeks of planned CAR-T cell infusion.
- Allogeneic stem cell transplant within 3 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents.
- Active graft versus host disease.
- Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases/central nervous system (CNS) disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Participants with a history of CNS or meningeal involvement must be in a documented remission by cerebrospinal fluid (CSF) evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.
- Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
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- A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
- HIV seropositivity.
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on screening bone marrow biopsy prior
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
- Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
- History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia)
The purpose of this study is to determine if it is possible to treat relapsed or refractory lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the immune system to treat the cancer).
Read the detailed description
This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose for this cellular therapy.
T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells, which then could be used to change the course of a disease. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called human chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active. The CAR-T cells will be returned to the body through an intravenous (IV) infusion. Another purpose of this study is to learn about the side effects and toxicities related to this treatment. Human CAR-T cell therapy is investigational (experimental) and works by removing T cells from the blood and modifying them to be able to target the cancer.
- Being tested
- Fully human anti CD19 CAR-T Cell Dose, Fludarabine, Cyclophosphamide
- Medical subject headings
- Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully human anti CD19 CAR-T Cell DoseBiological
Level -1 (1 x 10^5 cells/kg) Level 1 [Starting Dose] (5 x 10^5 cells/kg) Level 2 (1 x 10^6 cells/kg) Level 3 (2 x 10^6 cells/kg)
Infusion of CAR-T cells will occur over 5-30 minutes.
FludarabineDrug
Also called Fludara
25 mg/m2 daily from day -5 to -3
CyclophosphamideDrug
Also called Cytoxan, Endoxan, Neosar, Procytox
60mg/Kg on day -6
| Study group | Role | What they receive |
|---|---|---|
| Group A - NHL/CLL | Experimental | Upon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done.
Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3.
Participants with CD19+ lymphomas and chronic lymphocytic leukemia will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at dose level 1 (DL1) on day 0.
The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD. Receives: Biological: Fully human anti CD19 CAR-T Cell Dose; Drug: Fludarabine; Drug: Cyclophosphamide |
| Group B - ALL | Experimental | Upon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done.
Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3.
Participants with Acute Lymphoblastic Leukemia (and lymphoblastic lymphoma as a solid tumor equivalent) will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at DL1 on day 0 and 7.
The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD. Receives: Biological: Fully human anti CD19 CAR-T Cell Dose; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose of human anti-CD19 CAR-T cells
Recommended phase II dose of human anti-CD19 CAR-T cells
Measured: 24 months
Secondary outcomes (17)
Number of participants experiencing grade 3 or more adverse events
Toxicity profile for to infusion of fully human CAR-T cells, as measured by number of participants experiencing grade 3 or more adverse events
Measured: 18 months
Number of participants experiencing dose limiting toxicities
Toxicity profile for to infusion of fully human CAR-T cells, as measured by number of participants experiencing dose limiting toxicities
Measured: 18 months
Overall response rate (ORR)
ORR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 30 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
ORR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 60 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
ORR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 90 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
ORR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 6 months after day 0 (first CAR-T treatment)
Overall response rate (ORR)
ORR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 12 months after day 0 (first CAR-T treatment)
Complete response rate (CR)
CR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 30 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
CR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 60 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
CR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 90 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
CR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 6 months after day 0 (first CAR-T treatment)
Complete response rate (CR)
CR relapsed B cell malignancies treated with CAR-T cells targeting CD19
Measured: 12 months after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
PFS from time of infusion
Measured: 30 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
PFS from time of infusion
Measured: 60 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
PFS from time of infusion
Measured: 90 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
PFS from time of infusion
Measured: 6 months after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
PFS from time of infusion
Measured: 12 months after day 0 (first CAR-T treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start26 Apr 2021
- Primary completion11 Dec 2025
- Study completion1 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Tomlinson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Tomlinson, Case Comprehensive Cancer Center
- Investigators
- Benjamin Tomlinson, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732845
- Sponsor's protocol ID
- CASE2419
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie or influence the results observed from the study
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia)
- ClinicalTrials.gov ID
- NCT04732845
- Acronym / sponsor ID
- CASE2419
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Benjamin TomlinsonUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 1 Dec 2040 (estimated)
- First posted
- 1 Feb 2021 (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 purpose of this study is to determine if it is possible to treat relapsed or refractory lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the immune system to treat the cancer).
Detailed description
This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose for this cellular therapy.
T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer. Lentivirus is a family of viruses that can be used by scientists to alter cells, which then could be used to change the course of a disease. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called human chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active. The CAR-T cells will be returned to the body through an intravenous (IV) infusion. Another purpose of this study is to learn about the side effects and toxicities related to this treatment. Human CAR-T cell therapy is investigational (experimental) and works by removing T cells from the blood and modifying them to be able to target the cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - NHL/CLL | Experimental | Biological: Fully human anti CD19 CAR-T Cell Dose, Drug: Fludarabine, Drug: CyclophosphamideUpon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done. Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3. Participants with CD19+ lymphomas and chronic lymphocytic leukemia will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at dose level 1 (DL1) on day 0. The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD. |
| Group B - ALL | Experimental | Biological: Fully human anti CD19 CAR-T Cell Dose, Drug: Fludarabine, Drug: CyclophosphamideUpon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done. Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3. Participants with Acute Lymphoblastic Leukemia (and lymphoblastic lymphoma as a solid tumor equivalent) will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at DL1 on day 0 and 7. The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have relapsed or refractory non-Hodgkin lymphoma (NHL) (Group A - NHL/CLL), chronic lymphocytic leukemia (Group A - NHL/CLL) or acute lymphoblastic leukemia (Group B - ALL) treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.
- The participant's malignancy is CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
- Total bilirubin ≤ 1.5 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 time normal) or of non-hepatic origin
- AST (SGOT) ≤ 3 times institutional upper limit of normal
Key exclusion criteria (14 listed)
- Autologous transplant within 6 weeks of planned CAR-T cell infusion.
- Allogeneic stem cell transplant within 3 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents.
- Active graft versus host disease.
- Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases/central nervous system (CNS) disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Participants with a history of CNS or meningeal involvement must be in a documented remission by cerebrospinal fluid (CSF) evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.
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 |
|---|---|---|
| Fully human anti CD19 CAR-T Cell DoseLevel -1 (1 x 10^5 cells/kg) Level 1 [Starting Dose] (5 x 10^5 cells/kg) Level 2 (1 x 10^6 cells/kg) Level 3 (2 x 10^6 cells/kg) Infusion of CAR-T cells will occur over 5-30 minutes. | Biological | Group A - NHL/CLL, Group B - ALL |
| FludarabineAlso: Fludara25 mg/m2 daily from day -5 to -3 | Drug | Group A - NHL/CLL, Group B - ALL |
| CyclophosphamideAlso: Cytoxan, Endoxan, Neosar, Procytox60mg/Kg on day -6 | Drug | Group A - NHL/CLL, Group B - ALL |
Primary outcome
Recommended phase II dose of human anti-CD19 CAR-T cells
Time frame: 24 months
Recommended phase II dose of human anti-CD19 CAR-T cells
17 secondary outcomes
Number of participants experiencing grade 3 or more adverse events
Time frame: 18 months
Number of participants experiencing dose limiting toxicities
Time frame: 18 months
Overall response rate (ORR)
Time frame: 30 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
Time frame: 60 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
Time frame: 90 days after day 0 (first CAR-T treatment)
Overall response rate (ORR)
Time frame: 6 months after day 0 (first CAR-T treatment)
Overall response rate (ORR)
Time frame: 12 months after day 0 (first CAR-T treatment)
Complete response rate (CR)
Time frame: 30 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
Time frame: 60 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
Time frame: 90 days after day 0 (first CAR-T treatment)
Complete response rate (CR)
Time frame: 6 months after day 0 (first CAR-T treatment)
Complete response rate (CR)
Time frame: 12 months after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
Time frame: 30 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
Time frame: 60 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
Time frame: 90 days after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
Time frame: 6 months after day 0 (first CAR-T treatment)
Progression Free Survival (PFS)
Time frame: 12 months after day 0 (first CAR-T treatment)
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 23 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie or influence the results observed from the study
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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.
Benjamin Tomlinson, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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 Fully human anti CD19 CAR-T Cell Dose, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia, run by Benjamin Tomlinson 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 13 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: under way, not looking for participants, as of the sponsor's last update on 23 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?
Recommended phase II dose of human anti-CD19 CAR-T cells (time frame: 24 months). 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 23 Sep 2026.