Phase 2
Completed N=18
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Source: ClinicalTrials.gov NCT04030195 ↗Enrolled (actual)
18
Serious AEs
23.5%
Results posted
Jan 2023
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — NA 10^6 CAR T cells
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
NA | — |
| PRIMARY Number of Participants With Dose-Limiting Toxicities |
1; 0; 0 | — |
| SECONDARY Objective Response Rate |
2; 1; 3; 1; 0; 0 | — |
| SECONDARY Progression-free Survival (PFS) |
29.5; 29.0; 29.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04030195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.