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CAR T-cell Therapy
PBCAR0191 for Blood Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Imugene Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 (calculated using the CKD-EPI equation [Levey et al, 2009]). If there is a concern that eGFR calculation is not an accurate reflection of renal function, a 24-hour urine collection for creatinine clearance may be used at the investigator's discretion. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal (ULN), unless there is suspected disease in the liver. Total bilirubin <2.0 mg/dL, except in subjects with Gilbert's syndrome. Platelet count ≥50,000/μL and absolute neutrophil count of ≥1000/ μL. Platelet transfusions within 14 days of screening are not allowed except for subjects in B-ALL disease cohort with extensive bone marrow disease burden, in which case adequate bone marrow recovery after prior treatment is required to be documented. C-reactive protein (CRP) <2x ULN; subjects with CRP elevation within 2x ULN, ruling out infectious cause will be required. Left ventricular ejection fraction >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition scan performed within 1 month before starting lymphodepleting chemotherapy. ECHO results performed within 6 months before Screening and at least 28 days after the last cancer treatment may be acceptable if the subject has not received any treatment with cardiotoxicity risks. No clinically significant evidence of pericardial effusion or pleural effusion causing clinical symptoms and needing immediate intervention, based on the investigator's opinion. Any known effusion must be stable without need for drainage within 2 weeks of enrollment. No clinically significant renal/pulmonary comorbidities. Baseline oxygen saturation >92% on room air.
Subject has unequivocal r/r CD19+ B-ALL that has been confirmed by morphology, flow cytometry, or a validated minimal residual disease assay.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective for treating blood cancer.
Who is the study for?
Adults with aggressive CD19+ B-cell Non-Hodgkin's Lymphoma (NHL) or relapsed/refractory B-cell Acute Lymphoblastic Leukemia (ALL), who have tried at least two prior treatments, can join this trial. They should not have severe heart, lung, kidney, liver issues or active infections and must be HIV negative. Those with a history of CNS disease need to show clear recovery.Check my eligibility
What is being tested?
The study is testing PBCAR0191 in combination with Fludarabine and Cyclophosphamide for safety and effectiveness in treating NHL and ALL. It involves gradually increasing the dose to find the best balance between benefits and side effects.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, nausea; blood cell count changes leading to increased infection risk; organ inflammation; plus specific risks from chemotherapy like hair loss and mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia (B-ALL) is resistant or has returned and tests confirm it targets CD19.
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I've had no more than 2 treatments after my CAR T-cell therapy.
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I had CAR T therapy for cancer, responded well initially, but then my cancer came back.
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My aggressive B-cell NHL is confirmed to be CD19 positive from my last relapse.
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I do not have serious kidney or lung conditions.
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My disease can be measured or seen on scans.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had 7 or fewer treatments for my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation
Expansion Cohort
Secondary outcome measures
AE reporting
Complete response (CR) rate
Duration of Response (DoR)
+4 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose Level 4bExperimental Treatment3 Interventions
PBCAR0191, 500 x 10^6 CAR T cells (flat dose)
Group II: Dose Level 4Experimental Treatment3 Interventions
PBCAR0191, 6 x 10^6 CAR T cells per kg body weight as 2 administrations of 3 x 10^6 CAR T cells per kg body weight administered after a single lymphodepletion.
Group III: Dose Level 3aExperimental Treatment3 Interventions
PBCAR0191, 3 x 10^6 CAR T cells per kg body weight.
Group IV: Dose Level 2Experimental Treatment3 Interventions
PBCAR0191, 1 x 10^6 CAR T cells per kg body weight.
Group V: Dose Level 1Experimental Treatment3 Interventions
PBCAR0191, 3 x 10^5 CAR T cells per kg body weight.
In this study, PBCAR0191, allogeneic anti-CD19 CAR T Cells, is used to treat patients with relapsed or refractory (r/r) Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia.
Route of Administration: Intravenous infusion.
Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR0191 infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Imugene LimitedLead Sponsor
6 Previous Clinical Trials
228 Total Patients Enrolled
Precision BioSciences, Inc.Lead Sponsor
4 Previous Clinical Trials
165 Total Patients Enrolled
Monika Vainorius, MDStudy ChairPrecision BioSciences, Inc.
5 Previous Clinical Trials
313 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer type that might return in the next 2 years, besides my current B-ALL or NHL.I have active hepatitis B or C, or I have inactive hepatitis B and am on preventive treatment.I have had only one treatment for the aggressive part of my lymphoma.My heart, lungs, liver, kidneys, and bone marrow are functioning well.My kidney function, measured by eGFR, is above 30 mL/min.My B-cell lymphoma is aggressive, confirmed by a biopsy after failing CD19 therapy.I need urgent treatment because my tumor is causing blockages or pressing on blood vessels.My CRP levels are less than twice the upper limit of normal, without infection.I do not have active brain or spinal cord disease, and tests confirm this.I don't have an ongoing serious infection needing strong antibiotics 7 days before the trial.I have a condition that significantly weakens my immune system.I haven't had a severe high blood pressure crisis or brain issues from high blood pressure in the last 3 months.All my tests were done after my last treatment.I have not received a live vaccine in the last 4 weeks.I have had CD19 therapy, not including CAR T, within the last 3 months.My leukemia (B-ALL) is resistant or has returned and tests confirm it targets CD19.I have Philadelphia chromosome positive disease and cannot tolerate tyrosine kinase inhibitor therapy or my disease is resistant.My leukemia is confirmed to be CD19 positive and either resistant or has returned.I've had no more than 2 treatments after my CAR T-cell therapy.I haven't had cancer treatment with a biologic agent in the last 28 days or any cancer therapy in the last 10 days.My liver enzymes are within normal limits, or slightly elevated if I have liver disease.My blood platelet count is above 50,000 and neutrophil count is over 1,000.My heart pumps well, with an ejection fraction over 45%.I do not have serious kidney or lung conditions.I had CAR T therapy for cancer, responded well initially, but then my cancer came back.I do not have serious heart rhythm problems.I have a history of blood clots or significant bleeding disorders.I have a genetic condition like Fanconi anemia affecting my bone marrow.I do not have an active autoimmune disease needing strong medication now.My aggressive B-cell NHL is confirmed to be CD19 positive from my last relapse.My diagnosis was confirmed by a biopsy or a special needle test.I can provide a sample from my latest biopsy if I've never had a complete response.I have undergone at least 2 chemotherapy treatments as per standard care.I have not taken any prohibited medications in the last 7 days.I've had at least 2 chemotherapy treatments, or 1 if I have Richter's transformation.I have an active condition where my red blood cells are being destroyed faster than they can be made.I don't have fluid buildup around my heart or lungs that needs immediate treatment.My disease can be measured or seen on scans.My leukemia is either Burkitt (L3 ALL) or mixed-lineage.I have never had, nor do I currently have, any brain or spinal cord diseases.I do not have any uncontrolled heart conditions.I have not had a heart attack in the last 6 months.I do not have a brain disorder that makes me ineligible for treatment.I had a stem cell transplant within the last 3 months.I am experiencing symptoms of graft-versus-host disease.I had radiotherapy less than 4 weeks ago, which needs special approval.I am fully active or restricted in physically strenuous activity but can do light work.I have had 7 or fewer treatments for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level 2
- Group 3: Dose Level 3a
- Group 4: Dose Level 4
- Group 5: Dose Level 4b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the standard application of PBCAR0191?
"PBCAR0191 is a medication that helps patients with multiple sclerosis, mixed-cell type lymphoma, leukemia, myelocytic, acute, and retinoblastoma."
Answered by AI
How many different medical clinics are participating in this study?
"Presently, this trial is running in 12 hospitals. The locations of these facilities are Detroit, Indianapolis and New york as well other cities. If you decide to enroll in the trial, try selecting a site that is closest to your home to minimize travel."
Answered by AI
What are the most recent findings from research on PBCAR0191?
"PBCAR0191 was first trialled in 1997 at City of Hope Comprehensive Cancer Center. In the two decades since, 1274 completed trials have taken place with 928 active studies currently underway; a significant portion of these are based out of Detroit, Michigan."
Answered by AI
How many people can enroll in this research project?
"To carry out this clinical trial, we require 120 individuals that meet the pre-defined inclusion criteria. These prospective participants can come from different locations, such as Barbara Ann Karmanos Cancer Institute (Wayne State University) in Detroit, Michigan and Indiana Blood and Marrow in Indianapolis, Indiana."
Answered by AI
Are people with the required qualifications currently able to enroll in this clinical trial?
"That is correct. The trial, which was first posted on March 11th 2019 and last updated on April 18th 2022, is still looking for 120 participants from 12 different locations."
Answered by AI
What are the objectives of this research project?
"The purpose of this 12 month clinical trial is to determine the Maximum Tolerated Dose (MTD) . Additionally, researchers want to understand the Objective Response Rate for patients with B-ALL and NHL, assess Overall Survival, and finally Duration of Response."
Answered by AI
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