CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia

NCT07361029 | Recruiting Phase 1 DMC

• 1 other identifier: 2191207
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).

Conditions

Relapsed Refractory Acute Lymphoblastic Leukemia

Keywords

CD19 CAR T; relapsed/refractory acute lymphoblastic leukemia (ALL).

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  To assess the maximum tolerated dose, safety and tolerability of intravenous infusion of CD19 CAR T cells using based on incidence, nature, and severity of AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

  throughout study completion, Day1 to 5 years

Secondary Outcomes (11)

• Evaluate the success rate of product manufacturing

  Pre-infusion

• preliminary anti-tumor activity of CD19 CAR T cells in treated patients

  Day30 and Day 60

• Safety of CD19 CAR T cells

  Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly

• Safety of CD19 CAR T cells

  Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly]

• safety of CD19 CAR T cells

  Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly

Study Arms (1)

single arm dose finding

EXPERIMENTAL

Other: CAR T cells chimeric antigen receptor cells

Interventions

CAR T cells chimeric antigen receptor cells OTHER

CAR T Cells

single arm dose finding

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed informed consent form 3. Ability to comply with the study protocol 4. Relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL):
• Second or greater bone marrow (BM) relapse; or
• Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia; or
• Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
• Relapsed patients ineligible for Allogeneic Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
• Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant immunosuppression
• Relapsed after prior CAR T cell and still CD19 positive. . (Patients with a history of ≥grade CRS, ≥ grade 3 ICANS, or severe hypersensitivity reactions following prior CAR T-cell therapy should be excluded.) 5. BM with ≥5% lymphoblasts by morphologic assessment at screening 6. For relapsed patients, documentation of CD19 tumor expression in BM or peripheral blood by flow cytometry or immunohistochemistry within 1 month of study entry 7. Patients with a history of CNS or meningeal involvement must be in a documented clinical remission prior to registration.
• \. Alanine aminotransferase (ALT) ≤5 times the upper limit of normal for age 9. Bilirubin ≤2 x ULN 10. Patients with good renal function defined as Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min.
• \. Absolute Neutrophil Count (ANC): Patients must have an ANC ≥ 1.0 x 109
• /L without the use of growth factors 12. Platelet Count: Patients must have a platelet count ≥ 50 x 109/L without transfusion support within 7 days of screening.
• \. Absolute Lymphocyte Count: Patients must have an absolute lymphocyte count ≥ 0.5 x 109/L.
• \. Definition of Adequate Organ Function:
• Renal Function: Glomerular Filtration Rate (GFR) \> 60mL/min.
• Hepatic Function: AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome).
• Pulmonary Function: Adequate respiratory function defined as oxygen saturation ≥ 93% on room air.

You may not qualify if:

• Clinically Active central nervous system (CNS) involvement by malignancy
• History or presence of uncontrolled underlying seizure disorder not related to B-ALL
• History of or active clinically significant cardiovascular dysfunction, including any of the following:
• History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
• History of transient ischemic attack within 12 months prior to the CD19 CAR T cells infusion
• History of myocardial infarction within 36 months prior to the CD19 CAR T cells infusion
• Symptomatic congestive heart failure (NYHA class III/IV), unstable angina pectoris, cardiac arrhythmia requiring therapy
• Uncontrolled arrhythmias, or history of or active ventricular arrhythmia requiring medication
• Active or history of coronary heart disease that remains symptomatic
• Active or history of unstable or stable angina
• Left ventricular ejection fraction (LVEF) \< 45% confirmed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) scan
• Creatinine clearance \< 60
• Concomitant genetic syndromes associated with Bone Marrow (BM) failure states, such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome; patients with Down syndrome are not excluded
• Burkitt lymphoma/leukemia
• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead
• Miltenyi Biomedicine GmbH: collaborator

Study Sites (1)

King Faisal Specialist Hospital and Research Center

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Riad El Fakih

CONTACT

00966539056287; relfakih1@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Lymphoma / Myeloma

Model Details: Chimeric Antigen Receptor (CAR)-modified T cell (CD19)

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: January 22, 2026
• Study Start: July 29, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)