Clinical trial · Interventional
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR20A in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- 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 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.
Conditions
Conditions (9)
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 Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphoid Leukemia in Relapse | — | UNRESOLVED | — |
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin's Lymphoma Refractory | — | UNRESOLVED | — |
| Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| PBCAR20A | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level 1 of PBCAR20A CAR T cells
- description
- 1 x 10\^6 chimeric antigen receptor (CAR) T cells per kg body weight. In this study, PBCAR20A, allogeneic anti-cluster of differentiation (CD20) CAR T Cells, is used to treat patients with relapsed or refractory (r/r) CD20+ Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Route of Administration: Intravenous infusion (IV) Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
- interventionNames
- Genetic: PBCAR20A
- Drug: Fludarabine
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Dose Level 2 of PBCAR20A CAR T cells
- description
- 240 x 10\^6 CAR T cells (flat dose)
- interventionNames
- Genetic: PBCAR20A
- Drug: Fludarabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria Criteria for NHL: * r/r CD20+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue from the last relapse and corresponding pathology report. * Measurable or detectable disease according to the Lugano classification. * Primary refractory disease or r/r disease after a response to 2 prior regimens. Criteria for CLL/SLL: * Diagnosis of CD20+ CLL with indication for treatment based on the iwCLL guidelines and clinically measurable disease or SLL with measurable disease that is biopsy-proven SLL. * Previously failed/tolerant to at least 2 prior lines of systemic targeted therapy of known benefit. Criteria for both NHL and CLL/SLL: * Study participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Study participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. Key Exclusion Criteria: Criteria for NHL: * Requirement for urgent therapy due to mass effects such as bowel obstruction, spinal cord, or blood vessel compression. * Active central nervous system (CNS) disease. A negative computed tomography (CT)/magnetic resonance imaging (MRI) is required at Screening if the study participant has a history of CNS lymphoma. Criteria for NHL and CLL/SLL: * Active CNS disease. A negative lumbar puncture is required at Screening if the study participant has a history of CNS disease. * Previous malignancy, besides the malignancies of inclusion (B-cell NHL or CLL/SLL), that in the investigator's opinion, has a high risk of relapse in the next 2 years. * Active uncontrolled fungal, bacterial, viral, protozoal, or other infection. * Any form of primary immunodeficiency. * History of human immunodeficiency virus (HIV) infection. * Active hepatitis B or C. * Uncontrolled cardiovascular disease. * Hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening. * Presence of a CNS disorder that renders ineligible for treatment. * History of a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman Diamond syndrome, or any other known bone marrow failure syndrome. * Received ASCT within 45 days of Screening if the study participant has met the rest of the count requirements. * Must not have received systemic corticosteroid therapy for at least 7 days prior to initiating lymphodepletion chemotherapy. * Received a live vaccine within 4 weeks before Screening. * Radiotherapy within 4 weeks determined on a case-by-case basis. * Presence of a pleural/peritoneal/pericardial catheter. * Current use of any anticoagulant or antiplatelet therapy.
References
Publications (0)
Data not yet available