Acute Lymphoblastic Leukemia RecurrentPhase 1NCT03853616
MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)
A Phase 1 study testing MB-CART19.1 in people with Acute Lymphoblastic Leukemia Recurrent and B-cell Lymphoma Recurrent, run by Miltenyi Biomedicine GmbH at 9 sites in Germany.
Trial summary
This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
- What is being tested?
- MB-CART19.1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 9 sitesGermany
- Study dates
- 26 Nov 2018to Nov 2026
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients must have r/r CD19-expressing ALL or NHL/CLL
- CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL);
- Age ≥ 1 year (if deemed fit by treating investigator);
- Absolute CD3+ T cell count ≥100/μl;
- ECOG performance score of 0-2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening;
- No active Hepatitis B, Hepatitis C, HIV1/2;
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- No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential;
- Signed and dated informed consent/assent by patients
- and meet the following disease-specific criteria:
- ALL:
- patients with >5% blasts in BM (M2 or M3) after at least one standard chemotherapy and one salvage regimen who are ineligible for allogeneic stem cell transplant (alloSCT) or have refractory disease activity precluding alloSCT at this time, or
- patients who have relapsed post alloSCT at least 100 days posttransplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs.
- ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully cleared by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy).
- Pediatric aggressive NHL (1-17 years):
- patients after at least one salvage chemotherapy as bridge to alloSCT or
- patients ineligible for alloSCT or
- patients who have relapsed post alloSCT at least 100 days posttransplant, with not evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion.
- Adult NHL:
- patients after at least one standard chemotherapy and one salvage regimen as bridge to alloSCT or
- patients who are ineligible for alloSCT or
- patients who have relapsed post alloSCT at least 100 days posttransplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared by intrathecal chemotherapy at the time of inclusion.
- CLL:
- patients with r/r disease after established and approved treatment options have failed.
- patients not eligible or appropriate for conventional alloSCT.
Who cannot join
- Isolated CNS or testicular relapse in ALL;
- Isolated CNS lymphomas;
- Active solid brain metastases or history of solid brain metastases
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis);
- History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;
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- Pulmonary function: Patients with pre-existing severe lung disease or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on chest X-ray;
- Cardiac function: Fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography;
- Renal function: GFR ≤29 mL/min/1.73 m2 by CKD-EPI for patients 18 yrs (Levey et al. 2009) or creatinine clearance ≤29 mL/min/1.73 m2 by Schwartz formula (Schwartz et al. 1976) for patients <18 yrs of age;
- Liver function: Patients with a serum bilirubin >3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration in the estimation of the investigator;
- Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy;
- Pregnant or breast-feeding females;
- Medications:
- Systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis,
- Fludarabine/clofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, calcineurin inhibitors, blinatumomab) or investigational drugs or donor lymphocyte transfusions or radiation therapy within 30 days prior to apheresis,
- Alemtuzumab within 3 months prior to leukapheresis,
- Exception: Intrathecal chemotherapy is allowed prior to treatment, but should be discontinued in ALL and BL 10 days prior to MB-CART19.1 infusion to limit risk of neurotoxicities;
- Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment related toxicities;
- Intake of concomitant medication contraindicated for other reasons than hypersensitivity, e.g. live vaccines and fludarabine;
- Contraindication of trial related procedures as judged by the investigator, e.g. lumbar punctures for CSF sampling;
- Female patients of child-bearing potential not willing to practice a highly effective form of birth control from the time of enrollment and for 12 months after dosing the IMP;
- Male patients of fathering potential not willing to practice a highly effective form of birth control from the time of enrollment and for 12 months after dosing the IMP;
- Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials;
- Cerebral dysfunction, legal incapacity of adult patients;
- Committal to an institution on judicial or official order.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Charité - University clinic, pediatric clinic with focus on oncology and hematology
Berlin, 13353
Universitätsklinikum Erlangen
Erlangen, 91054
University medicine Goettingen, Clinic of hematology and medical oncology
Göttingen, 37075
Children's Hospital of Dr. von Hauner by Ludwig-Maximilian University
Munich, 80337
Universitätsklinikum Münster - Klink für Kinderheilkunde und Jugendmedizin / Pädiatrische Hämatologie und Onkologie
Münster, 48149
Universitätsklinikum Münster - Medizinische Klinik A / KMT Zentrum
Münster, 48149
Tuebingen University clinic, medical university clinic for internal medicine
Tübingen, 72076
University clinic for children and youth medicine
Tübingen, 72076
University clinic, pediatric hematology and oncology
Würzburg, 97070
About this study
Official title: A Phase I Safety, Dose Finding and Feasibility Trial of MB-CART19.1 in Patients With Relapsed or Refractory CD19 Positive B Cell Malignancies
This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Read the detailed description
This trial will evaluate the safety of the MB-CART19.1 and determine the recommended dose levels for each of the three disease cohorts.
Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1 and in Cohort 3 with Dose Level 2, sparing Dose Level 1 (see figure 1). Each of the cohorts will evaluate the safety of MB-CART19.1.
In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable.
Cohort 3 will Start with Dose Level 2. If Dose Level 2 is not tolerated, Dose Level 1 will be tested. DLT will be evaluated within 4 weeks after the infusion of MB-CART19.1. An interval of at least 28 days between the treatment of the first and the second patient in each dose level (and in each cohort) is mandatory.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-CART19.1Biological
Also called CD19-targeting CAR T cells, Anti-CD19 CAR T cells
MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD19-positive tumor cells in b cell malignancies
| Study group | Role | What they receive |
|---|---|---|
| DL 0: 1x10e5 MB-CART19.1 cells | Experimental | In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Receives: Biological: MB-CART19.1 |
| DL 1: 5x10e5 MB-CART19.1 cells | Experimental | Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Receives: Biological: MB-CART19.1 |
| DL 2: 1x10e6 MB-CART19.1 cells | Experimental | Dose evaluation will start in Cohort 3 with Dose Level 2, sparing Dose Level 1. If Dose Level 2 is not tolerated, Dose Level 1 will be tested. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Receives: Biological: MB-CART19.1 |
| DL 3: 3x10e6 MB-CART19.1 cells | Experimental | In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable. Receives: Biological: MB-CART19.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the recommended dose of MB-CART19.1
Maximum tolerated dose (MTD), defined as the highest dose level of the two to three dose levels tested at which <33% of patients experience DLT until day 28 after infusion of MB-CART19.1, on the basis of safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.
Measured: until day 28 after infusion of MB-CART19.1
Secondary outcomes (11)
Overall incidence and severity of adverse events
per adverse events (AE) reporting classified according to CTCAE version 5.0
Measured: through study completion, an average of 5 years
Response to treatment for each timepoint
ORR in ALL (Rate of CR/CRh)
Measured: day 28
Response to treatment for each timepoint
Rate MRD-negative CR in ALL
Measured: day 28, week 12, month 6, 1 year
Response to treatment for each timepoint
ORR in NHL/CLL (Rate of CR/PR)
Measured: day 28, patients not in CR on day 28: month 3
Occurence of B-cell depletion
Circulating B cell numbers
Measured: through study completion, an average of 5 years
Phenotype and persistence of MB-CART19.1
Blood samples for determination of persistence/phenotyping of infused MB-CART19.1 will be analysed
Measured: days 2, 7, 10, 14, 28, weeks 8, 12, months 6, 12, 24, 36, 48, 60
Number of patients with successful MB-CART19.1 production
Number of patients meeting the inclusion criteria and none of the exclusion criteria for who an autologous MB-CART19.1 product can be generated
Measured: day 0
Rate of ALL patients achieving MRD negative CR
Rate MRD-negative CR in ALL
Measured: day 28, week 12, month 6, 1 year
Duration of response
Determination of response rate
Measured: through study completion, an average of 5 years
Disease-free survival
disease-free survival at 1 year after adoptive immunotherapy with MB-CART19.1 in patients not receiving alloSCT
Measured: at 1 year after MB-CART19.1 infusion in patients not receiving alloSCT
Overall survival
overall survival at 1 year after adoptive immunotherapy with MB-CART19.1 in patients not receiving alloSCT
Measured: at 1 year after MB-CART19.1 infusion in patients not receiving alloSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start26 Nov 2018
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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 RecurrentStudies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Rössig, Prof. Dr., Principal investigator, Univeristy Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853616
- Sponsor's protocol ID
- M-2017-322
- Other IDs
- 2017-002848-32, 2017
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety, Dose Finding and Feasibility Trial of MB-CART19.1 in Patients With Relapsed or Refractory CD19 Positive B Cell Malignancies
- ClinicalTrials.gov ID
- NCT03853616
- Acronym / sponsor ID
- M-2017-322
- Conditions
- Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory, Chronic Lymphocytic Leukemia Recurrent, Chronic Lymphocytic Leukemia Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Feb 2019 (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 is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Detailed description
This trial will evaluate the safety of the MB-CART19.1 and determine the recommended dose levels for each of the three disease cohorts.
Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1 and in Cohort 3 with Dose Level 2, sparing Dose Level 1 (see figure 1). Each of the cohorts will evaluate the safety of MB-CART19.1.
In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable.
Cohort 3 will Start with Dose Level 2. If Dose Level 2 is not tolerated, Dose Level 1 will be tested. DLT will be evaluated within 4 weeks after the infusion of MB-CART19.1. An interval of at least 28 days between the treatment of the first and the second patient in each dose level (and in each cohort) is mandatory.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DL 0: 1x10e5 MB-CART19.1 cells | Experimental | Biological: MB-CART19.1In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. |
| DL 1: 5x10e5 MB-CART19.1 cells | Experimental | Biological: MB-CART19.1Dose evaluation will start in Cohorts 1 and 2 with Dose Level 1. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. |
| DL 2: 1x10e6 MB-CART19.1 cells | Experimental | Biological: MB-CART19.1Dose evaluation will start in Cohort 3 with Dose Level 2, sparing Dose Level 1. If Dose Level 2 is not tolerated, Dose Level 1 will be tested. In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. |
| DL 3: 3x10e6 MB-CART19.1 cells | Experimental | Biological: MB-CART19.1In each dose level of each of the three cohorts three 3 + 3 patients will be treated. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. In Dose Level 3, three additional patients will be treated, if no DLT occurred. Dose Level 0 will be tested only if Dose Level 1 is not tolerable. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female patients must have r/r CD19-expressing ALL or NHL/CLL
- CD19 expression must be detected on the malignant cells by flow cytometry (leukemia, malignant effusion in NHL) or immunohistochemistry (NHL);
- Age ≥ 1 year (if deemed fit by treating investigator);
- Absolute CD3+ T cell count ≥100/μl;
- ECOG performance score of 0-2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening;
Key exclusion criteria (25 listed)
- Isolated CNS or testicular relapse in ALL;
- Isolated CNS lymphomas;
- Active solid brain metastases or history of solid brain metastases
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis);
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 |
|---|---|---|
| MB-CART19.1Also: CD19-targeting CAR T cells, Anti-CD19 CAR T cellsMB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD19-positive tumor cells in b cell malignancies | Biological | DL 0: 1x10e5 MB-CART19.1 cells, DL 1: 5x10e5 MB-CART19.1 cells, DL 2: 1x10e6 MB-CART19.1 cells, DL 3: 3x10e6 MB-CART19.1 cells |
Primary outcome
Determination of the recommended dose of MB-CART19.1
Time frame: until day 28 after infusion of MB-CART19.1
Maximum tolerated dose (MTD), defined as the highest dose level of the two to three dose levels tested at which <33% of patients experience DLT until day 28 after infusion of MB-CART19.1, on the basis of safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.
11 secondary outcomes
Overall incidence and severity of adverse events
Time frame: through study completion, an average of 5 years
Response to treatment for each timepoint
Time frame: day 28
Response to treatment for each timepoint
Time frame: day 28, week 12, month 6, 1 year
Response to treatment for each timepoint
Time frame: day 28, patients not in CR on day 28: month 3
Occurence of B-cell depletion
Time frame: through study completion, an average of 5 years
Phenotype and persistence of MB-CART19.1
Time frame: days 2, 7, 10, 14, 28, weeks 8, 12, months 6, 12, 24, 36, 48, 60
Number of patients with successful MB-CART19.1 production
Time frame: day 0
Rate of ALL patients achieving MRD negative CR
Time frame: day 28, week 12, month 6, 1 year
Duration of response
Time frame: through study completion, an average of 5 years
Disease-free survival
Time frame: at 1 year after MB-CART19.1 infusion in patients not receiving alloSCT
Overall survival
Time frame: at 1 year after MB-CART19.1 infusion in patients not receiving alloSCT
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Claudia Rössig, Prof. Dr. principal investigator
Univeristy Hospital Muenster
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB-CART19.1 in people with Acute Lymphoblastic Leukemia Recurrent and B-cell Lymphoma Recurrent, run by Miltenyi Biomedicine GmbH at 9 sites in Germany.
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 27 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. 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?
Determination of the recommended dose of MB-CART19.1 (time frame: until day 28 after infusion of MB-CART19.1). 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 9 Oct 2026.