Clinical trial · Interventional
CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous 3rd generation CD19-targeting CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR T cells
- description
- Autologous 3rd generation CD19-targeting CAR T cells
- interventionNames
- Biological: Autologous 3rd generation CD19-targeting CAR T cells
Primary outcomes (1)
- measure
- CAR T cell persistence
- timeFrame
- At week 1 and 5, there after every 3 months post treatment up to 24 months
- description
- Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.
Secondary outcomes (1)
- measure
- Tumor load
- timeFrame
- Every 3 months post treatment up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory CD19+ B-cell lymphoma or leukemia. * Measurable disease. * Performance status ECOG 0-2. * \>18 years old. * Fertile females/males must consent to use contraceptives during participation of the trial. * Signed informed consent. Exclusion Criteria: * Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. * Patients with primary CNS lymphoma. * Known human immunodeficiency virus (HIV) infection. * Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). * Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. * Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest. * Patients that do not consent to that tissue and blood samples are stored in a biobank. * Pregnancy
References
Publications (2)
- DERIVEDErnst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. PMID 34515338
- DERIVEDEnblad G, Karlsson H, Gammelgard G, Wenthe J, Lovgren T, Amini RM, Wikstrom KI, Essand M, Savoldo B, Hallbook H, Hoglund M, Dotti G, Brenner MK, Hagberg H, Loskog A. A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia. Clin Cancer Res. 2018 Dec 15;24(24):6185-6194. doi: 10.1158/1078-0432.CCR-18-0426. Epub 2018 Aug 10. PMID 30097433