Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaPhase 1/2CARLLA-B1NCT07890025
CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
A Phase 1/2 study testing MB-CART19.1 in people with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
This is a Phase I/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
- What is being tested?
- MB-CART19.1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 1/2
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- From 18 to 60 years old
- Signed informed consent prior to participation in the study
- Diagnosis of relapsed or refractory B-cell ALL after at least two lines of treatment
- Documented CD19 positivity either by immunohistochemistry analysis or flow cytometry in the last available evaluation
- ECOG performance status ≤2
- Women of childbearing potential must have a negative serum pregnancy test
- Adequate renal, hepatic, pulmonary, and cardiac function
- Bone marrow function specifications at least 48 hours prior to recruitment: hemoglobin ≥8 g/dL, absolute neutrophil count (ANC) ≥500/µL, absolute lymphocyte count ≥300/µL, platelet count ≥30,000/µL
Who cannot join
- Recipient of CAR-T cell therapy outside this protocol
- Active involvement of the central nervous system or meninges by any neoplasm (patients with a history of CNS or meningeal involvement must be in documented remission by CSF evaluation for at least 90 days before registration)
- History of active malignant neoplasm other than the underlying B-cell ALL, excluding non-melanoma skin cancer
- Active or ongoing infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illnesses/social situations that would limit compliance with the study requirements
- Pregnant or breastfeeding women
- Evidence of myelodysplasia in bone marrow aspirate before the start of treatment
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- Active infection by human immunodeficiency virus (HIV)
- Serologic status that reflects active infection by hepatitis B or C
- History of COVID-19 infection in the last 3 months
- Grade 1 or higher adverse events associated with SARS-CoV-2, with the exception of peripheral neuropathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: An Open-Label, Single-Center, Phase I/II Study Evaluating the Safety and Efficacy of a CAR T Cell Therapy Targeting CD19, in Adult Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
This is a Phase I/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL).
Read the detailed description
This Phase I/II, open-label, single-center, single-arm, dose-escalation study is designed to evaluate the safety and efficacy of MB-CART19.1 in adult patients with r/r B-cell ALL. The primary objective is to determine the safety and tolerability of MB-CART19.1 and to establish the recommended Phase II dose (RP2D). Secondary objectives include the overall response rate (ORR), complete remission rate (CR), overall survival (OS), event-free survival (EFS), and leukemia-free survival (LFS).
Adult patients (18 to 60 years of age) with r/r B-cell ALL who have received at least two prior lines of therapy will be enrolled. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. A 3+3 dose-escalation design will be used, and all patients will receive a single infusion of MB-CART19.1 on Day 0, at a dose level assigned according to the disease burden at the time of pre-conditioning.
- Being tested
- MB-CART19.1
- Keywords
- CAR-T, Acute lymphoblastic leukemia
- Medical subject headings
- Recurrence, Burkitt Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-CART19.1Biological
MB-CART19.1 are autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19.
| Study group | Role | What they receive |
|---|---|---|
| High disease burden (≥5% bone marrow blasts) | Experimental | Patients with ≥5% blasts in bone marrow at the time of lymphodepletion receive a single infusion of MB-CART19.1, with the cell dose assigned by dose level according to a 3+3 dose-escalation design: De-escalation Level 1x10^5 CAR-positive cells/kg; Dose Level 1 (starting dose) 5x10^5; Dose Level 2, 1x10^6; Dose Level 3, 2x10^6. Receives: Biological: MB-CART19.1 |
| Low disease burden (<5% bone marrow blasts) | Experimental | Patients with <5% blasts in bone marrow at the time of lymphodepletion receive a single infusion of MB-CART19.1, with the cell dose assigned by dose level according to a 3+3 dose-escalation design: De-escalation Level, 5x10^5 CAR-positive cells/kg; Dose Level 1 (starting dose), 1x10^6; Dose Level 2, 2x10^6; Dose Level 3, 5x10^6. Receives: Biological: MB-CART19.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) and determination of the recommended Phase II dose (RP2D)
Safety and tolerability of MB-CART19.1 assessed by the incidence of dose-limiting toxicities (DLTs), defined as grade >=3 adverse events considered related to MB-CART19.1 or the lymphodepletion regimen occurring within 30 days after infusion. The RP2D is defined as the maximum tolerated dose (MTD), or the highest dose level studied if the MTD is not reached, using a 3+3 dose-escalation design.
Measured: 30 days post-infusion
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Overall safety of MB-CART19.1 assessed by the frequency and severity of treatment-emergent AEs and SAEs.
Measured: Up to 24 months post-infusion
Secondary outcomes (5)
Overall response rate (ORR)
Proportion of patients achieving an overall response, defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi), assessed by bone marrow morphology and flow cytometry.
Measured: Day 30 and Day 100 post-infusion
Complete remission rate with negative measurable residual disease (MRD)
Proportion of patients achieving complete remission with negative MRD, defined as <0.001% residual leukemic cells in bone marrow by multiparameter flow cytometry.
Measured: Day 30 and Day 100 post-infusion
Overall survival (OS)
Time from study entry to death from any cause.
Measured: Up to 24 months post-infusion
Event-free survival (EFS)
Time from MB-CART19.1 infusion to the first of the following events: absence of response, disease progression, relapse after achieving CR or CRi, or death from any cause.
Measured: Up to 24 months post-infusion
Leukemia-free survival (LFS)
Time from documentation of complete remission to disease relapse or death related to the disease, whichever occurs first.
Measured: Up to 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- David Gómez Almaguer, MD, Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890025
- Sponsor's protocol ID
- HE25-00021
- Acronym
- CARLLA-B1
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study will be made available to qualified external researchers. The data to be shared will include individual participant-level data for all pre-specified primary and secondary outcome measures, after de-identification. Requests will be granted after review by the Research Ethics Committee of the Hospital Universitario "Dr. Jose Eleuterio Gonzalez". Data will be provided following the execution of a data sharing/transfer agreement and in accordance with applicable Mexican personal data protection laws.
Publications
Ghobadi A, Caimi PF, Reese JS, Goparaju K, di Trani M, Ritchey J, Jackson Z, Tomlinson B, Schiavone JM, Kleinsorge-Block S, Zamborsky K, Eissenberg L, Schneider D, Boughan KM, Zabor EC, Metheny L, Gallogly M, Kruger W, Kadan M, Worden A S A, Sharma A, Cooper BW, Otegbeye F, Sekaly RP, Wald DN, Carlo-Stella C, DiPersio J, Orentas R, Dropulic B, de Lima M. Treatment of non-Hodgkin lymphoma with point-of-care manufactured CAR T cells: a dual institution, phase 1 trial. EClinicalMedicine. 2025 Mar 4;81:103138. doi: 10.1016/j.eclinm.2025.103138. eCollection 2025 Mar.
PubMed 40115173Muller F, Taubmann J, Bucci L, Wilhelm A, Bergmann C, Volkl S, Aigner M, Rothe T, Minopoulou I, Tur C, Knitza J, Kharboutli S, Kretschmann S, Vasova I, Spoerl S, Reimann H, Munoz L, Gerlach RG, Schafer S, Grieshaber-Bouyer R, Korganow AS, Farge-Bancel D, Mougiakakos D, Bozec A, Winkler T, Kronke G, Mackensen A, Schett G. CD19 CAR T-Cell Therapy in Autoimmune Disease - A Case Series with Follow-up. N Engl J Med. 2024 Feb 22;390(8):687-700. doi: 10.1056/NEJMoa2308917.
PubMed 38381673Mackensen A, Hanssens L, Stelljes M, Bethge WA, Feuchtinger T, Kunkele A, et al. A Phase I Open Label Dose Escalation Study of MB-CART19.1 in Relapsed and Refractory CD19+ B Cell Malignancies, Interim Preliminary Results in Pediatric ALL, Adult ALL Including CLL Cohorts. Blood. 2021;138(Supplement 1):3836. doi:10.1182/blood-2021-152452.