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Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Phase 1, PHASE2 trial testing PBCAR20A in Non-Hodgkin's Lymphoma, Relapsed in 18 participants. Completed in 24 June 2021.
| Lead sponsor | Precision BioSciences, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 24 March 2020 |
| Primary completion | 24 June 2021 |
| Estimated completion | 24 June 2021 |
| Sites | 5 locations across United States |
Precision BioSciences, Inc. — full company profile →
18 and older, any sex, with Non-Hodgkin's Lymphoma, Relapsed or Chronic Lymphoid Leukemia in Relapse. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
| Group | Value | 95% CI |
|---|---|---|
| PBCAR20A CAR T Cells | NA |
Dose-limiting toxicities (DLT) are certain Grade 3 and Grade 4 toxic reactions as defined by the protocol and CTCAE v5.0.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 1 | |
| Dose Level 2 of PBCAR20A CAR T Cells | 0 | |
| Dose Level 3 of PBCAR20A CAR T Cells | 0 |
Objective response rate (ORR) is a measure of clinical activity as response in NHL by the revised Lugano Classification (Cheson et al, 2016) or a response in CLL/SLL by the International Workshop on Chronic Lymphocytic Leukemia 2018 guidelines.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 2 | |
| Dose Level 2 of PBCAR20A CAR T Cells | 1 | |
| Dose Level 3 of PBCAR20A CAR T Cells | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 1 | |
| Dose Level 2 of PBCAR20A CAR T Cells | 0 | |
| Dose Level 3 of PBCAR20A CAR T Cells | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 1 | |
| Dose Level 2 of PBCAR20A CAR T Cells | 1 | |
| Dose Level 3 of PBCAR20A CAR T Cells | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 6 | |
| Dose Level 2 of PBCAR20A CAR T Cells | 2 | |
| Dose Level 3 of PBCAR20A CAR T Cells | 4 |
Progression-free survival is defined as the duration (days) from Day 0 to disease progression or death.
| Group | Value | 95% CI |
|---|---|---|
| Dose Level 1 of PBCAR20A CAR T Cells | 29.5 | 15.0 – 365.0 |
| Dose Level 2 of PBCAR20A CAR T Cells | 29.0 | 29.0 – 94.0 |
| Dose Level 3 of PBCAR20A CAR T Cells | 29.0 | 12.0 – 66.0 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dose Level 1 of PBCAR20A C… | Dose Level 2 of PBCAR20A C… | Dose Level 3 of PBCAR20A C… |
|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| Transaminases increased | Investigations | — | — | — |
| CAR T cell-related encephalopathy syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Reaction | System | Dose Level 1 of PBCAR20A C… | Dose Level 2 of PBCAR20A C… | Dose Level 3 of PBCAR20A C… |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Fatigue | General disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Cytokine release syndrome | Immune system disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | — | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Somnolence | Nervous system disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — |
| Vision blurred | Eye disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Anal incontinence | Gastrointestinal disorders | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Asthenia | General disorders | — | — | — |
| Chills | General disorders | — | — | — |
| Gait disturbance | General disorders | — | — | — |
| Generalised oedema | General disorders | — | — | — |
Most-reported serious reactions: Atrial fibrillation, Abdominal pain, Pneumonia, Sepsis, Transaminases increased, CAR T cell-related encephalopathy syndrome.
Data from ClinicalTrials.gov NCT04030195 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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