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Phase 2 Completed N=18 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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