Who is sponsoring NCT06559189?

NCT06559189 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT06559189?

Interventions in NCT06559189: CD19x22 CAR T.

What condition does NCT06559189 study?

NCT06559189 studies B-cell Acute Lymphoblastic Leukemia.

Is NCT06559189 still recruiting?

NCT06559189 is currently recruiting now. Last updated 21 November 2025.

Last reviewed 2025-11-21 · How we verify

NCT06559189

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting now Phase 1 Last updated 21 November 2025

What this trial tests

Phase 1 trial testing CD19x22 CAR T in B-cell Acute Lymphoblastic Leukemia in 53 participants. Currently enrolling.

Timeline

27 September 2024

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	27 September 2024
Primary completion	1 December 2028
Estimated completion	1 December 2029
Sites	1 location across United States

Drugs / interventions tested

CD19x22 CAR T — full drug profile →

Conditions studied

B-cell Acute Lymphoblastic Leukemia — all drugs for B-cell Acute Lymphoblastic Leukemia →

Sponsor

University of Colorado, Denver

Who can join

Adults 3 Months to 30, any sex, with B-cell Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety Measured by Dose Limiting Toxicities (DLTs)
Time frame: Infusion date to 28 days post-infusion
The safety of the administering this bispecific CD19/CD22-directed CAR T cell product will be measured by assessing the DLTs in each disease burden cohort in a Bayesian optimal interval (BOIN) design to determine the MTD

Sponsor's own description

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
Advances in ligand-targeted nanodelivery systems for leukemia therapy: from single- to dual-ligand strategies.
Hu M, He C, Hao J, Qi N, et al · · 2026 · PMID 41772642 · DOI 10.1186/s12967-026-07966-w
Increased NFAT activity with dual CAR stimulation in CD19xCD22 CAR T-cells is associated with decreased exhaustion and improved survival.
Rankin AW, Pham-Danis C, Novak AJ, Danis E, et al · · 2025 · PMID 41238217 · DOI 10.1136/jitc-2025-011971

Verify or expand the search:

Other recruiting trials for B-cell Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

NCT06326008 — Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-deri · Phase 1 · recruiting
NCT07153796 — A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemoth · Phase 2 · recruiting
NCT06863259 — Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL · Phase 1 · recruiting
NCT06793241 — Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia · EARLY_PHASE1 · recruiting
NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06559189 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 21 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06559189.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing