Clinical trial · Interventional
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen
- 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 an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRO131921 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PRO131921
Primary outcomes (1)
- measure
- Dose-limiting toxicities and adverse events
- timeFrame
- Length of study
Secondary outcomes (2)
- measure
- Pharmacokinetic parameters; CD19-positive B-cell counts
- timeFrame
- Length of study
- measure
- Overall response; and progression-free survival (Ph. 2 only)
- timeFrame
- Length of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Signed informed consent * Ability and willingness to comply with the requirements of the study protocol * Age ≥ 18 years * Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL * Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen * Bi-dimensionally measurable disease, with at least one lesion \>1.5 cm in its largest dimension * Absolute B-cell count ≥LLN at screening (Phase I only) * ECOG performance status of 0, 1, or 2 * For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment * For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment Exclusion Criteria: * Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy) * Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment * Current or recent lymphoma treatment * History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies * Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders * Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination * Untreated or persistent/recurrent malignancy (other than lymphoma) * Known active bacterial, viral, fungal, mycobacterial, or other infection * A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening * History of recurrent significant infection or bacterial infections * Positive hepatitis B or C serology * Positive human immunodeficiency virus (HIV) serology * Pregnancy or lactation * Central nervous system lymphoma * Recent major surgery within 4 weeks of screening, other than diagnostic surgery
References
Publications (0)
Data not yet available