RecruitingAcute Lymphoblastic LeukemiaDiffuse Large B Cell Lymphoma
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.
Sponsor: University of Utah
You may qualify if…
- ✓ Subjects aged ≥ 18 years.
- ✓ Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome, primary CNS lymphoma. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.
- ✓ Subjects who are relapsed or refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
- ✓ ECOG Performance Status ≤ 2.
- ✓ Life expectancy \> 12 weeks.
- ✓ Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation
- ✓ Adequate organ function as defined as:
- ✓ Hematologic:
You may not qualify if…
- ✕ Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.
- ✕ Subjects with active infection that requires systemic treatment
- ✕ History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
- ✕ Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
- ✕ Receiving other investigational agents.
- ✕ Confirmation that washout periods listed in Appendix 10 have been followed.
- ✕ Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
- ✕ The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). Patients with transformed disease are allowed.
Where it's recruiting
Utah
Salt Lake City
Source: ClinicalTrials.gov · NCT06227026 · last updated 2026-08-26