CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study

NCT07890025 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HE25-00021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Keywords

CAR-T; Acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 24 months post-infusion

Secondary Outcomes (5)

• Overall response rate (ORR)

  Day 30 and Day 100 post-infusion

• Complete remission rate with negative measurable residual disease (MRD)

  Day 30 and Day 100 post-infusion

• Overall survival (OS)

  Up to 24 months post-infusion

• Event-free survival (EFS)

  Up to 24 months post-infusion

• Leukemia-free survival (LFS)

  Up to 24 months post-infusion

Study Arms (2)

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.

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.

Biological: MB-CART19.1

Interventions

MB-CART19.1 BIOLOGICAL

MB-CART19.1 are autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19.

High disease burden (≥5% bone marrow blasts); Low disease burden (<5% bone marrow blasts)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (3)

• 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.

  PMID: 40115173 BACKGROUND

• Muller 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.

  PMID: 38381673 BACKGROUND

• Mackensen 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.

  BACKGROUND

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• David Gómez Almaguer, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrés Gómez De León, MD

CONTACT

+52 8183486136; drgomezdeleon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Hematology Service at the University Hospital and UANL

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ME (1)