Clinical trial · Interventional
CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies
Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies
NCT04156243CI-TRIAL-00041574unknownEarly Phase 1ClinicalTrials.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)
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
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 |
|---|---|---|---|
| CD19 CARvac T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CARvac T cells
- description
- CD19 CARvac T cells transduced with a lentiviral vector to express
- interventionNames
- Biological: CD19 CARvac T cells
Primary outcomes (3)
- measure
- Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- timeFrame
- 28 days
- measure
- Type of dose-limiting toxicity (DLT)
- timeFrame
- 28 days
- measure
- Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis based on the World Health Organization (WHO) 2008 2. Patients have exhausted standard therapeutic options 3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 4. Female must be not pregnant during the study Exclusion Criteria: 1. Prior solid organ transplantation 2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
References
Publications (1)
- DERIVEDLiu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available. PMID 32840736