Clinical trial · Interventional
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies
NCT04450069CI-TRIAL-00079957completedPhase 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)
CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma (MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CLBR001 and SWI019 | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- CLBR001 + SWI019 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD)
- interventionNames
- Combination Product: CLBR001 and SWI019
Primary outcomes (2)
- measure
- Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events
- timeFrame
- 35 days
- description
- To determine the frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events
- measure
- Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
- timeFrame
- up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017) * Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors * Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease * Patients must be ineligible for allogeneic stem cell transplant (SCT) * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered * Willing to undergo pre- and post-treatment core needle biopsy * Adequate hematological, renal, pulmonary, cardiac, and liver function * Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1 * Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control * Men sexually active with female partners of child bearing potential must agree to practice effective contraception * Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures Exclusion Criteria: * Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma * Pregnant or lactating women * Active bacterial, viral, and fungal infections * History of allogeneic stem cell transplantation * Treatment with any prior lentiviral or retroviral based CAR-T * Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study * Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible * History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening * Involvement of cardiac tissue by lymphoma * Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) * HIV-1 and HIV-2 antibody positive patients
References
Publications (3)
- BACKGROUNDRodgers DT, Mazagova M, Hampton EN, Cao Y, Ramadoss NS, Hardy IR, Schulman A, Du J, Wang F, Singer O, Ma J, Nunez V, Shen J, Woods AK, Wright TM, Schultz PG, Kim CH, Young TS. Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies. Proc Natl Acad Sci U S A. 2016 Jan 26;113(4):E459-68. doi: 10.1073/pnas.1524155113. Epub 2016 Jan 12. PMID 26759369
- BACKGROUNDViaud S, Ma JSY, Hardy IR, Hampton EN, Benish B, Sherwood L, Nunez V, Ackerman CJ, Khialeeva E, Weglarz M, Lee SC, Woods AK, Young TS. Switchable control over in vivo CAR T expansion, B cell depletion, and induction of memory. Proc Natl Acad Sci U S A. 2018 Nov 13;115(46):E10898-E10906. doi: 10.1073/pnas.1810060115. Epub 2018 Oct 29. PMID 30373813
- 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