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Tests treatment safety and results for Non-Hodgkin Lymphoma
Official title Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
ClinicalTrials.gov ID: NCT03666000
What this study is testing
What is Azer-cel?
Azer-cel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Also referred to as Allogeneic Anti-CD19 CAR T cells, PBCAR0191.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Criteria for B-ALL:
- Participant has confirmed unequivocal r/r CD19+ B-ALL. Criteria for NHL and CLL/SLL:
- Participant has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy...
- Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation
- Follicular lymphoma (FL) including Grade 3 or transformed FL
You likely can't join if
- Criteria for B-ALL:
- Burkitt cell (L3 ALL) or mixed-lineage acute leukemia. Criteria for NHL:
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.
- Active hemolytic anemia. Criteria for B-ALL and NHL:
- No active CNS disease, excluding PCNSL
- History of another primary malignancy
See the full eligibility criteria
- Key Criteria for B-ALL:
- Participant has confirmed unequivocal r/r CD19+ B-ALL. Criteria for NHL and CLL/SLL:
- Participant has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy. For Phase 1 Dose Escalation:
- Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation
- Follicular lymphoma (FL) including Grade 3 or transformed FL
- High-grade B-cell lymphoma (HGBCL)
- Primary mediastinal lymphoma For Phase 1b Dose Expansion (CAR T-relapsed cohort):
- DLBCL not otherwise specified (NOS)
- HGBCL
- DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma [MZL], and Waldenstrom's Macroglobulinemia [WM])
- Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the Medical Monitor.
- Participants previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product.
- For the expansion CAR T-relapsed cohort only: Participants must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse or...
- DLBCL NOS
- DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)
- HGBCL
- FL (Grade 1-3a)
- MZL that is fluorodeoxyglucose (FDG)-avid on positron emission tomography (PET) scan
- CLL/SLL
- Primary central nervous system (CNS) lymphoma (PCNSL)
- Other LBCL subtypes may be enrolled with approval from the Medical Monitor.
- Participant must have received at least 1-2 prior lines of therapy, depending on histological subtype but no more than 7 systemic lines of anti-cancer therapy. Criteria for both B-ALL, NHL, and CLL/SLL:
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- An estimated life expectancy of at least 12 weeks according to the investigator's judgment.
- Seronegative for human immunodeficiency virus antibody.
- Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. Key
- Criteria for B-ALL:
- Burkitt cell (L3 ALL) or mixed-lineage acute leukemia. Criteria for NHL:
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.
- Active hemolytic anemia. Criteria for B-ALL and NHL:
- No active CNS disease, excluding PCNSL
- History of another primary malignancy
- Any form of primary immunodeficiency (for example, severe combined immunodeficiency disease).
- History of hepatitis B or hepatitis C currently receiving ongoing antiviral therapy. Any known uncontrolled cardiovascular disease at the time of Screening that, in the investigator's opinion, renders the participant...
- History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Presence of a CNS disorder that, in the opinion of the investigator, renders the participant ineligible for treatment.
- History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.
- Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding participants needing steroids for physiologic replacement).
- Participant has received stem cell transplant within 90 days before Screening.
- Participant has active graft-versus-host disease (GvHD) symptoms.
- Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD, other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD, and no...
- Radiotherapy within 4 weeks before Screening.
- Presence of pleural/peritoneal/pericardial catheter, as well as permeant biliary and ureteral stents (does not apply to intravenous lines).
- Participant has received live vaccine within 4 weeks before Screening. Note: Non-live virus vaccines are not excluded.
- Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD. Additional criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Duarte, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- Camperdown, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Adelaide, South Australia, Australia
- Fitzroy, Victoria, Australia
- Geelong, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Duarte, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.