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CD19x22 CAR T Cells for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This study is testing a new cell therapy called CD19x22 CAR T Cells for adolescents and adults with B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or not responded to previous treatments (relapsed/refractory). This therapy uses your own immune cells, called T cells, which are specially modified to recognize and fight cancer cells. The main goal is to find out how safe and tolerable CD19x22 CAR T Cells are, and to determine the best dose to use in future studies. Researchers will also look at how well the treatment works. You may be eligible if you are 16 years or older and have certain types of B-NHL. The study's current status is unclear, and it plans to enroll 68 participants.

Study design
This is an open-label, single-arm Phase 1 study, meaning all participants will receive the study treatment and both you and the researchers will know which treatment is being given. It aims to enroll 68 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor your safety and tolerability for 12 months after you receive the infusion. They will also look at how well the treatment works at 90 days and 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05098613

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

Recruiting
PHASE1Ages 16+InterventionalTreatment
University of Colorado, Denver
~68 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:CD19x22 CAR T Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall safety and tolerability of CD19x22 CAR T Therapy in CAR-naive and CAR-treated subjects
Measured over 12 Months Post Infusion
+1 more outcome measured

Conditions

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

Explore related trials

B-Cell Non-Hodgkin LymphomaDiffuse Large B-Cell LymphomaHigh Grade B-Cell LymphomaMantle Cell LymphomaPrimary Central Nervous System LymphomaPrimary Mediastinal Large B-Cell LymphomaSecondary CNS LymphomaCD19 GeneCD22 GeneTP53 Gene

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Manali Kamdar, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Derek Schatz
[email protected]
7208480628
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Positive blood culture within 48 hours of the start of the apheresis procedure, OR
Fever \>38.2°C AND clinical signs of infection within 48 hours of start of apheresis procedure
CBC with manual differential
Lymphocyte enumeration (TBNK) panel to measure CD3 count
CD3 count must be \>0.15 x 106 cells/mL
If the participant received bridging therapy after apheresis, confirmation of disease reevaluation is required. It must be within 6 weeks of initiation of LD chemotherapy.
Confirmation that the participant has met the washout period for bridging therapy.
Negative serum pregnancy test (for women of childbearing potential)
Adequate organ function as defined by:
Absolute neutrophil count (ANC) ≥ 500/μL.
Platelet count ≥ 50,000/ μL.
Renal: Creatinine ≤ 2 mg/dL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL/min.
Hepatic: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).
Total bilirubin ≤ 2 mg/dl, except in subjects with Gilbert's syndrome where a bilirubin \<3.0 will be acceptable.
Pulmonary: No clinically significant pleural effusion and; Baseline oxygen saturation must be \> 92% on room air.
Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO) (only if subject received bridging anthracycline or developed a significant illness prior to LD-chemo per investigator assessment.) If clinically indicated, ECHO must be performed within 2 weeks prior to LD-chemotherapy.
Cohort 3 patients ONLY:
Patients must not have steroid-dependent CNS lymphoma, defined as requiring more than 1 mg/kg/day or prednisone or equivalent within 14 days prior to the start of LD chemotherapy.
Patients may not have poorly controlled hydrocephalus prior to the initiation of LD chemotherapy.
CD19x22 CAR T cells must have met manufacturing release criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA).
Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).
ECOG ≤2 or Karnofsky≥ 50%.
Clinically stable without evidence of vital sign instability, including the lack of supportive vasoactive drugs or intensive care unit support.
Oxygen saturation \> 92% on room air; cannot be on supplemental oxygen.
No evidence of uncontrolled, significant tumor lysis syndrome prior to cell infusion per investigator assessment.
No evidence of rapidly progressive NHL per investigator determination.
Participants' temperature is \<38.0 °C within 48 hours prior to cell infusion. (If the source of fever cannot be identified \[after thorough infectious disease work-up\], and the suspected cause is underlying malignancy, discussion and approval by the Gates Institute Medical Lead may allow continued infusion of CD19x22 cells. This should be appropriately documented in the patient's medical record.
Liver transaminase (ALT and AST) \< 5 x institutional ULN (\< grade 3) based on age- and laboratory- specific normal ranges.
Adequate renal function as defined by creatinine ≤ 2 mg/dL OR creatinine clearance (as estimated by the Cockcroft- Gault equation) ≥ 60 mL/min.

What this trial measures

  • Overall safety and tolerability of CD19x22 CAR T Therapy in CAR-naive and CAR-treated subjects12 Months Post Infusion

    Assessed by Type, Frequency, and Severity of Adverse Events (AEs). All AEs, including laboratory abnormalities, will be graded using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading criteria.

  • Determine the Recommended Phase II Dose (RP2D) Level30 Days Post Infusion

    Incidence and frequency of Grade 3-5 toxicity occurring within the dose limiting toxicity (DLT) period post CD19x22 CAR T infusion. Grades 3-5 adverse events (AEs) are defined as Severe, Life-Threatening, and Fatal.