NCT03233854

CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies

Active, enrolled Phase 1 Last updated 18 November 2025

What this trial tests

Phase 1 trial testing Chimeric Antigen Receptor T-Cell Therapy in B Acute Lymphoblastic Leukemia in 56 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2017

Primary endpoint
20 June 2023

1 September 2035

Quick facts

Lead sponsor	Stanford University
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 September 2017
Primary completion	20 June 2023
Estimated completion	1 September 2035
Sites	1 location across United States

Drugs / interventions tested

• Chimeric Antigen Receptor T-Cell Therapy — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
• Laboratory Biomarker Analysis
• Questionnaire Administration
• NKTR-255

Conditions studied

• B Acute Lymphoblastic Leukemia — all drugs for B Acute Lymphoblastic Leukemia →
• CD19 Positive — all drugs for CD19 Positive →
• Minimal Residual Disease — all drugs for Minimal Residual Disease →
• Philadelphia Chromosome Positive — all drugs for Philadelphia Chromosome Positive →

Sponsor

Stanford University

Who can join

18 and older, any sex, with B Acute Lymphoblastic Leukemia or CD19 Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy and NKTR-255, and to see how well they work in treating patients with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on diffuse large B-cell lymphoma and B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. Giving CD19/CD22-CAR T cells and chemotherapy in combination with NKTR-255 may work better in treating patients with diffuse large B-cell lymphoma or B acute lymphoblastic leukemia.

Publications & conference data

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

1. Engineering strategies to overcome the current roadblocks in CAR T cell therapy.
   Rafiq S, Hackett CS, Brentjens RJ. · · 2020 · cited 1111× · PMID 31848460 · DOI 10.1038/s41571-019-0297-y
2. Mechanisms of resistance to CAR T cell therapy.
   Shah NN, Fry TJ. · · 2019 · cited 804× · PMID 30837712 · DOI 10.1038/s41571-019-0184-6
3. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial.
   Spiegel JY, Patel S, Muffly L, Hossain NM, et al · · 2021 · cited 492× · PMID 34312556 · DOI 10.1038/s41591-021-01436-0
4. Engineered T Cell Therapy for Cancer in the Clinic.
   Zhao L, Cao YJ. · · 2019 · cited 275× · PMID 31681259 · DOI 10.3389/fimmu.2019.02250
5. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
6. 2021 Update on Diffuse large B cell lymphoma: A review of current data and potential applications on risk stratification and management.
   Susanibar-Adaniya S, Barta SK. · · 2021 · cited 250× · PMID 33661537 · DOI 10.1002/ajh.26151
7. Preclinical Development of Bivalent Chimeric Antigen Receptors Targeting Both CD19 and CD22.
   Qin H, Ramakrishna S, Nguyen S, Fountaine TJ, et al · · 2018 · cited 203× · PMID 30581986 · DOI 10.1016/j.omto.2018.10.006
8. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449