NCT05098613

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)

Recruiting now Phase 1 Last updated 17 December 2025

What this trial tests

Phase 1 trial testing CD19x22 CAR T Cells in Non-Hodgkin Lymphoma in 68 participants. Currently enrolling.

Timeline

21 December 2021

Primary endpoint
1 December 2026

1 December 2027

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	68
Start date	21 December 2021
Primary completion	1 December 2026
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

• CD19x22 CAR T Cells — full drug profile →

Conditions studied

• Non-Hodgkin Lymphoma — all drugs for Non-Hodgkin Lymphoma →
• B-cell Non-Hodgkin Lymphoma (B-NHL) — all drugs for B-cell Non-Hodgkin Lymphoma (B-NHL) →
• Mantle Cell Lymphoma (MCL) — all drugs for Mantle Cell Lymphoma (MCL) →
• CNS Lymphoma — all drugs for CNS Lymphoma →

Sponsor

University of Colorado, Denver

Who can join

16 and older, any sex, with Non-Hodgkin Lymphoma or B-cell Non-Hodgkin Lymphoma (B-NHL). 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.

• Overall safety and tolerability of CD19x22 CAR T Therapy in CAR-naive and CAR-treated subjects
  Time frame: 12 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) Level
  Time frame: 30 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.

Sponsor's own description

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.

Publications & conference data

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

1. CD19/22 CAR T cells in children and young adults with B-ALL: phase 1 results and development of a novel bicistronic CAR.
   Shalabi H, Qin H, Su A, Yates B, et al · · 2022 · cited 122× · PMID 35605184 · DOI 10.1182/blood.2022015795
2. Characteristics of the cancer stem cell niche and therapeutic strategies.
   Ju F, Atyah MM, Horstmann N, Gul S, et al · · 2022 · cited 84× · PMID 35659296 · DOI 10.1186/s13287-022-02904-1
3. Advances in CAR-T Cell Genetic Engineering Strategies to Overcome Hurdles in Solid Tumors Treatment.
   Andrea AE, Chiron A, Mallah S, Bessoles S, et al · · 2022 · cited 48× · PMID 35211124 · DOI 10.3389/fimmu.2022.830292
4. Deleting the mitochondrial respiration negative regulator MCJ enhances the efficacy of CD8⁺ T cell adoptive therapies in pre-clinical studies.
   Wu MH, Valenca-Pereira F, Cendali F, Giddings EL, et al · · 2024 · cited 15× · PMID 38789421 · DOI 10.1038/s41467-024-48653-y
5. Emerging frontiers in immuno- and gene therapy for cancer.
   Gustafson MP, Ligon JA, Bersenev A, McCann CD, et al · · 2023 · cited 13× · PMID 36280438 · DOI 10.1016/j.jcyt.2022.10.002
6. Therapeutic landscape of primary refractory and relapsed diffuse large B-cell lymphoma: Recent advances and emerging therapies.
   Bock AM, Epperla N. · · 2025 · cited 8× · PMID 40597378 · DOI 10.1186/s13045-025-01702-5
7. Mapping the cancer surface proteome in search of target antigens for immunotherapy.
   Di Meo F, Kale B, Koomen JM, Perna F. · · 2024 · cited 8× · PMID 39068512 · DOI 10.1016/j.ymthe.2024.07.019
8. Chimeric Antigen Receptor-T Cell Therapy for Lymphoma: New Settings and Future Directions.
   Benevolo Savelli C, Clerico M, Botto B, Secreto C, et al · · 2023 · cited 8× · PMID 38201473 · DOI 10.3390/cancers16010046