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Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and/or Refractory B-Non-Hodgkin's Lymphoma (B-NHL)

NCT05098613•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.

Detailed Description

To determine the safety and tolerability of infusing CD19x22 CAR T, generated using a bicistronic vector, in adolescents and adults with R/R B-NHL, and to determine the recommended Phase II dose (RP2D). Secondary objectives for all subjects include: 1) Feasibility of manufacturing and infusion, 2) Safety of infusion and 3) Efficacy: Descriptive characterization of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) at Day +90. As well, progression-free survival (PFS), overall survival (OS), duration of remission (DOR) and overall response rate (ORR) will be determined at 1 year. Efficacy will be descriptively stratified based on prior receipt of CAR-T cell therapy.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Age: ≥ 16 years of age with no upper age limit. (NOTE: the first three subjects on this trial must be ≥ 18 years of age.)
•COHORT 1: Non-CNS B-NHL
•1. Histologically confirmed aggressive B-cell NHL including the following types defined by World Health Organization (WHO) 2008:
•a. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr Virus (EBV)+ DLBCL of the elderly; OR b. Primary mediastinal (thymic) large B cell lymphoma; OR c. Transformation to DLBCL; OR d. High grade B-cell Lymphoma (HGBL).
•2. Subjects must not have any signs or symptoms of CNS disease or detectable evidence of CNS disease on magnetic resonance imaging (MRI) at screening; subjects who have been previously treated for CNS disease, but have no evidence of disease at screening are eligible for this cohort.
•3. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least two lines of therapy.
•a. The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment.
•b. Relapse or refractory after single antigen targeting CAR T cell therapy
•4. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
•COHORT 2: MANTLE CELL LYMPHOMA (MCL)
+30 more criteria

Exclusion Criteria

•1. Age \< 16 years of age.
•2. Patient who is intolerant of contrast-enhanced MRI due to allergic reactions to contrast agents. Only applicable to Cohort 3.
•3. History of other malignancies, unless they have been disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ and localized prostate cancer not on active treatment.
•4. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; uncomplicated infections are permitted if responding to active treatment.
•5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \[HBsAg\] positive) or hepatitis C.
•6. History of known myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.
•7. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.
•8. Any medical condition that in the judgement of the sponsor is likely to interfere with assessment of safety or efficacy of study treatment.
•9. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
•10. Pregnancy (serum pregnancy test must be obtained at time of enrollment for females of childbearing potential and to be repeated 72 hours prior to lymphodepleting chemotherapy regimen); females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be childbearing potential.
+29 more criteria

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Key Dates

Start Date

December 21, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Non-Hodgkin LymphomaB-cell Non-Hodgkin Lymphoma (B-NHL)Mantle Cell Lymphoma (MCL)CNS Lymphoma

Interventions

CD19x22 CAR T Cells

DRUG

Contacts

Derek Schatz

CONTACT

7208480628 derek.schatz@cuanschutz.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Inclusion Criteria

Exclusion Criteria

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