Clinical trial · Interventional
CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy
CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy - a Phase II Trial.
NCT03068416CI-TRIAL-00054554completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety 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 |
|---|---|---|---|
| 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: CAR T cells
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 24 months
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes (5)
- measure
- Tumor response
- timeFrame
- 24 months.
- description
- Determination of tumor size
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed or refractory CD19+ B-cell lymphoma or leukemia with no other curative treatment option available. 2. Measurable disease. 3. All ages 4. Performance status ECOG 0-2. 5. Fertile females/males must consent to use contraceptives during participation of the trial. 6. Signed informed consent. Exclusion Criteria: 1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. Patients with primary CNS lymphoma. 3. Known human immunodeficiency virus (HIV) infection. 4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. 5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient to perform the treatment. 6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest. 7. Pregnancy 8. Patients that do not consent to that tissue and blood samples are stored in a biobank 9. Patients whose cells cannot be manufactured.
References
Publications (1)
- DERIVEDSaren T, Ramachandran M, Gammelgard G, Lovgren T, Mirabello C, Bjorklund AK, Wikstrom K, Hashemi J, Freyhult E, Ahlstrom H, Amini RM, Hagberg H, Loskog A, Enblad G, Essand M. Single-Cell RNA Analysis Reveals Cell-Intrinsic Functions of CAR T Cells Correlating with Response in a Phase II Study of Lymphoma Patients. Clin Cancer Res. 2023 Oct 13;29(20):4139-4152. doi: 10.1158/1078-0432.CCR-23-0178. PMID 37540566