Acute Lymphoblastic Leukemia, in RelapseEarly Phase 1NCT05779930
Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL
A Early Phase 1 study testing CD19 specific Chimeric Antigen Receptor T Cell in people with Acute Lymphoblastic Leukemia, in Relapse and Non-Hodgkin's Lymphoma, Relapsed, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory
- What is being tested?
- CD19 specific Chimeric Antigen Receptor T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Dec 2035
- Phase
- Early 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.
- Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
- Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.
- Meets criteria for non-hematopoietic organ function:
- Renal function: Estimated glomerular filtration rate ≥60 mL/min x appropriate estimation of patient's body surface area m2/1.73m2 using the modified Schwartz formula for pediatric patients and Crockcoft Gault formula for adults.
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- Liver function: Total bilirubin ≤ 2 mg/dl or ≤ 2.5 x ULN for age (unless Gilbert's syndrome) and ALT and AST ≤ 5 x ULN for age (unless related to leukemic involvement)
- Cardiac function: left ventricular ejection fraction ≥40%
- Pulmonary function: minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation >91% on room air
- Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator.
- Signed consent by parent/guardian and assent if appropriate for subjects < 18 years of age. Signed consent by patient/subject if ≥18 years of age.
Who cannot join
- Acute/ongoing neurologic toxicity > Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 1 months.
- Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.
- Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
- Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment
- Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening
- Pregnant or nursing (lactating) women.
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- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- HIV positive test within 8 weeks of screening
- Allogeneic HSCT within 3 months of enrollment
- Any prior CD19 CAR T cell therapy
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
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To examine the feasibility of manufacture and administration of autologous CD19 CAR T cells at a minimum target dose of 0.3 x 10^6 to 1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg using the Miltenyi CliniMACS Prodigy automated T Cell Transduction (TCT) process.
- To evaluate the safety of administration of CD19 CAR T cells after lymphodepletion with fludarabine and cyclophosphamide.
SECONDARY OBJECTIVE:
- To estimate the efficacy of CD19 specific CAR-T cells in pediatric and young adult patients with relapsed/refractory CD19+ B-cell ALL and NHL.
EXPLORATORY OBJECTIVE:
- To evaluate the persistence of CD19 CAR T cells after infusion.
The autologous lymphocytes are collected from the patient via apheresis. The apheresis product is then transported to the on-site GMP facility for manufacture of the CAR T cell product. Patients may be admitted to begin lymphodepleting chemotherapy during the CAR T cell manufacturing process. When the CAR T cell product is ready, the cells may be administered fresh or may be cryopreserved for use at a later date depending on the patient's clinical status.
All patients will be admitted to the hospital to undergo a Fludarabine/Cyclophosphamide based leukoreduction conditioning regimen to be completed 2-14 days prior to CAR T cell infusion. Patients will be admitted for a minimum of 7 days after the CAR T infusion to monitor for toxicity including cytokine release syndrome, neurologic toxicity, and tumor lysis syndrome.
Lymphodepleting chemotherapy:
- Fludarabine 30 mg/m2/day IV x 4 days
- Cyclophosphamide 500 mg/m2/day IV x 2 days
CD19 CAR T cell dose:
- 0.3 x 10^6 to 1 x 10^6 per kilogram for patients <50 kg
- Flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Non Hodgkin Lymphoma, B Cell Leukemia
- Being tested
- CD19 specific Chimeric Antigen Receptor T Cell
- Keywords
- ALL, NHL, CD19 CAR T cells
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Recurrence, Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 specific Chimeric Antigen Receptor T CellBiological
Infusion of CD19 CAR-T Cells manufactured on-site using the CliniMACS Prodigy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Leukopharesis: cells collected with a target of ≥1 x10^9 TNC with ≥3% CD3+ cells.
Lymphodepleting chemotherapy: 4 days of IV chemotherapy with fludarabine and cyclophosphamide.
* Fludarabine 30 mg/m2/day IV x 4 days (days -6 through -3)
* Cyclophosphamide 500 mg/m2/day IV x 2 days (days -6 and-5)
anti-CD19 CAR T cells:
* 0.3 - 1 x 10^6 per kilogram for patients <50 kg
* Flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg
The cell infusion will take place on day 0 (at least 2 days after completion of lymphodepleting chemotherapy). The patient will receive pre-medication with acetaminophen and diphenhydramine 30-60 minutes prior to the cell infusion. Receives: Biological: CD19 specific Chimeric Antigen Receptor T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of products successfully manufactured and infused with a goal of 0.3-1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3-1 x 10^8 for patients ≥50 kg
Reported as the proportion of products successfully manufactured and infused
Measured: 4 years
Incidence and severity of adverse events
Summarized with descriptive statistics
Measured: Up to 1 year after CAR T cell infusion
Secondary outcomes (6)
Overall response rate
Proportion of patients achieving a response at 1 month post infusion
Measured: 1 year
Complete response rate for B cell Acute Lymphoblastic Leukemia
Complete response rate at 1 month post infusion
Measured: Measured 1 month post-infusion
Best overall response for B cell Non-Hodgkin's Lymphoma
Best overall response (complete response, partial response, stable disease, progressive disease)
Measured: 1 year
MRD negative response rates for Acute Lymphoblastic Leukemia
MRD status at 30 days post infusion will be presented with descriptive statistics. MRD will be performed utilizing both flow cytometry and NGS.
Measured: Measured 1 month post-infusion
Overall survival
Overall survival and event free survival will be assessed using the Kaplan-Meier method. Survival will be measured as the time from cell infusion to event or censoring.
Measured: up to 15 years
Event free survival
Overall survival and event free survival will be assessed using the Kaplan-Meier method. Survival will be measured as the time from cell infusion to event or censoring.
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study startOct 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, unblinded, pilot treatment study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Lamb, Nationwide Children's Hospital
- Investigators
- Margaret Lamb, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779930
- Sponsor's protocol ID
- AutoCAR19
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of On-Site Manufacture of CD19 CAR T Cells Using the CliniMACS Prodigy in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05779930
- Acronym / sponsor ID
- AutoCAR19
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Non Hodgkin Lymphoma, B Cell Leukemia
- Keywords
- ALL, NHL, CD19 CAR T cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 22 Mar 2023 (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 pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Detailed description
PRIMARY OBJECTIVE:
- To examine the feasibility of manufacture and administration of autologous CD19 CAR T cells at a minimum target dose of 0.3 x 10^6 to 1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg using the Miltenyi CliniMACS Prodigy automated T Cell Transduction (TCT) process.
- To evaluate the safety of administration of CD19 CAR T cells after lymphodepletion with fludarabine and cyclophosphamide.
SECONDARY OBJECTIVE:
- To estimate the efficacy of CD19 specific CAR-T cells in pediatric and young adult patients with relapsed/refractory CD19+ B-cell ALL and NHL.
EXPLORATORY OBJECTIVE:
- To evaluate the persistence of CD19 CAR T cells after infusion.
The autologous lymphocytes are collected from the patient via apheresis. The apheresis product is then transported to the on-site GMP facility for manufacture of the CAR T cell product. Patients may be admitted to begin lymphodepleting chemotherapy during the CAR T cell manufacturing process. When the CAR T cell product is ready, the cells may be administered fresh or may be cryopreserved for use at a later date depending on the patient's clinical status.
All patients will be admitted to the hospital to undergo a Fludarabine/Cyclophosphamide based leukoreduction conditioning regimen to be completed 2-14 days prior to CAR T cell infusion. Patients will be admitted for a minimum of 7 days after the CAR T infusion to monitor for toxicity including cytokine release syndrome, neurologic toxicity, and tumor lysis syndrome.
Lymphodepleting chemotherapy:
- Fludarabine 30 mg/m2/day IV x 4 days
- Cyclophosphamide 500 mg/m2/day IV x 2 days
CD19 CAR T cell dose:
- 0.3 x 10^6 to 1 x 10^6 per kilogram for patients <50 kg
- Flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, unblinded, pilot treatment study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: CD19 specific Chimeric Antigen Receptor T CellLeukopharesis: cells collected with a target of ≥1 x10^9 TNC with ≥3% CD3+ cells. Lymphodepleting chemotherapy: 4 days of IV chemotherapy with fludarabine and cyclophosphamide. * Fludarabine 30 mg/m2/day IV x 4 days (days -6 through -3) * Cyclophosphamide 500 mg/m2/day IV x 2 days (days -6 and-5) anti-CD19 CAR T cells: * 0.3 - 1 x 10^6 per kilogram for patients <50 kg * Flat dose of 0.3 - 1 x 10^8 for patients ≥50 kg The cell infusion will take place on day 0 (at least 2 days after completion of lymphodepleting chemotherapy). The patient will receive pre-medication with acetaminophen and diphenhydramine 30-60 minutes prior to the cell infusion. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry at most recent relapse or reconfirmed after CD19 directed therapy in ALL patients. For patients with NHL, documentation of CD19 positivity must be available from biopsy at diagnosis or most recent tumor biopsy.
- Age 0 to age 30 at the time of initial diagnosis. Note: the first three subjects enrolled must be ≥16 years of age
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
- Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are eligible if there is documented evidence of disease stabilization for at least 1 month prior to CD19 CAR T cell infusion.
- Meets criteria for non-hematopoietic organ function:
Key exclusion criteria (10 listed)
- Acute/ongoing neurologic toxicity > Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 1 months.
- Active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic.
- Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
- Presence of Grade 2 to 4 acute or extensive chronic graft versus-host disease (GVHD) at the time of enrollment
- Patient has participated in an investigational research study using an investigational agent within the last 30 days prior to screening
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 specific Chimeric Antigen Receptor T CellInfusion of CD19 CAR-T Cells manufactured on-site using the CliniMACS Prodigy | Biological | Treatment |
Primary outcome
Proportion of products successfully manufactured and infused with a goal of 0.3-1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3-1 x 10^8 for patients ≥50 kg
Time frame: 4 years
Reported as the proportion of products successfully manufactured and infused
Incidence and severity of adverse events
Time frame: Up to 1 year after CAR T cell infusion
Summarized with descriptive statistics
6 secondary outcomes
Overall response rate
Time frame: 1 year
Complete response rate for B cell Acute Lymphoblastic Leukemia
Time frame: Measured 1 month post-infusion
Best overall response for B cell Non-Hodgkin's Lymphoma
Time frame: 1 year
MRD negative response rates for Acute Lymphoblastic Leukemia
Time frame: Measured 1 month post-infusion
Overall survival
Time frame: up to 15 years
Event free survival
Time frame: up to 15 years
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 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Margaret Lamb, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19 specific Chimeric Antigen Receptor T Cell in people with Acute Lymphoblastic Leukemia, in Relapse and Non-Hodgkin's Lymphoma, Relapsed, run by Nationwide Children's 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 11 inclusion and 10 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 15 Aug 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Clelie Peck (614-722-5634, clelie.peck@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of products successfully manufactured and infused with a goal of 0.3-1 x 10^6 per kilogram for patients <50 kg and a flat dose of 0.3-1 x 10^8 for patients ≥50 kg (time frame: 4 years). 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?
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 15 Aug 2025.