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New treatment option for Acute Lymphoid Leukemia
Official title UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
ClinicalTrials.gov ID: NCT05535855
What this study is testing
What is CD19 Directed CAR T Cell?
CD19 Directed CAR T Cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoid leukemia.
Also referred to as UCD19 CAR T cells.
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 open-label, single arm Phase 1/1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 for apheresis, treatment with lymphodepleting chemotherapy, and UCD19 CAR T cell infusion.
- Phase 1: an early, usually small safety study
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
- Age: ≥ 18 years of age with no upper age limit
- ECOG Performance Status ≤ 2
- Confirmed B-cell ALL in first complete morphologic remission
- MRD positivity as defined by:
- For Ph- ALL: \> 0.01% by FACS or \> 0 clonal sequences by NGS (clonoSEQ). MRD assessment for eligibility must be at least 28 days after the start of...
You likely can't join if
- Previous CAR T therapy.
- Relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have evidence of MRD after having previously documented...
- Mixed phenotype acute leukemia or Burkitt's lymphoma
- Not in hematological remission at time of enrollment (Remission is defined as \< 5% blasts)
- Signs or symptoms of active CNS disease or detectable evidence of CNS disease on MRI at the time of screening. people who have been previously...
- History of malignancy unless disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ (e.g., cervix...
See the full eligibility criteria
Who can join
- Age: ≥ 18 years of age with no upper age limit
- ECOG Performance Status ≤ 2
- Confirmed B-cell ALL in first complete morphologic remission
- MRD positivity as defined by:
- For Ph- ALL: \> 0.01% by FACS or \> 0 clonal sequences by NGS (clonoSEQ). MRD assessment for eligibility must be at least 28 days after the start of SOC induction therapy. Remission-induction therapy must have consisted...
- For Ph+ ALL: \> 0.01% by FACS, \> 0 clonal sequences by NGS (clonoSEQ), or less than complete molecular remission (undetectable BCR-ABL1 transcripts by RT-PCR assay with sensitivity of at least 1 in 100,000). MRD...
- Peripheral blood CD3 count must be \> 0.15 x 106 cells/mL within 21 days prior to proceeding with apheresis.
- Toxicities from prior therapy must be stable and recovered to ≤ Grade 2 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in 7).
- Adequate organ function as defined by:
- Absolute neutrophil count (ANC) ≥ 500/μL.
- Platelet count ≥ 50,000/μL.
- Renal: Either Creatinine ≤ 2 mg/dL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL/min.
- Hepatic: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 mg/dL, except in people with Gilbert's syndrome where a bilirubin \< 3.0 mg/dL will be acceptable.
- Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings at the time of...
- Pulmonary: No clinically significant pleural effusion. i. Baseline oxygen saturation \> 92% on room air and; ii. Pulmonary Function Test: Diffuse capacity of the lungs for carbon monoxide (DLCO), forced expiratory...
- Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of...
- people of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the UCD19 infusion.
- Must be able to give informed consent; people unable to give informed consent will not be eligible for this study.
- Be able to consent to long-term follow-up protocol (#20-0188).
What rules you out
- Previous CAR T therapy.
- Relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have evidence of MRD after having previously documented MRD-negative remission.
- Mixed phenotype acute leukemia or Burkitt's lymphoma
- Not in hematological remission at time of enrollment (Remission is defined as \< 5% blasts)
- Signs or symptoms of active CNS disease or detectable evidence of CNS disease on MRI at the time of screening. people who have been previously treated for CNS disease but have no evidence of disease at screening are...
- History of malignancy unless disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).
- Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active...
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma...
- Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.
- Any medical condition that in the judgement of the Sponsor is likely to interfere with assessment of safety or how well it works of study treatment.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Females planning to become pregnant during the course of the study. Apheresis Eligibility In order to proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21...
- Disease restaging studies will be performed as clinically indicated but must be within 14 days prior to initiation of lymphodepletion.
- Peripheral blood for CD3 count must be obtained within 21 days prior to apheresis and, therefore, is not applicable for determining lymphodepleting chemotherapy eligibility.
- In lieu of exclusion criteria #4, there must be no evidence of rapidly progressive disease prior to LD chemotherapy initiation per Investigator assessment. Bridging disease directed antineoplastic therapy is allowed...
- Medical history and Baseline Abnormalities
- Medical history (defined as ongoing medical conditions identified before the subject's first study-specific intervention (i.e., initiation of LD Chemotherapy on Day -5).
- Baseline abnormalities refer to abnormal clinical findings (e.g., laboratory values, vital signs, ECG results, etc.) identified before the start of LD Chemotherapy that may or may not be related to the subject's...
- All medical history and baseline abnormalities should be entered in the eCRF. Events should be assessed within 30 days prior to enrollment until LD Chemotherapy. Grading per CTCAE v5.0 should reflect the patient's...
- Physical exam UCD19 CAR T Cell Infusion Eligibility Participants must meet the following criteria in order for cells to be infused (based on labs obtained within 24 hours of cell infusion):
- UCD19 CAR T Cells must have met release criteria.
- Performance status determination (ECOG must be ≤ 2).
- Participant remains clinically stable without evidence of vital sign instability.
- Must not have ALT/SGPT and AST/SGOT \> 10x the ULN or bilirubin \>2x the ULN, (unless history of Gilberts syndrome where bilirubin must not be \>3x ULN).
- Adequate renal function as defined in the Inclusion Criteria.
- No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator. If these criteria are not met, measures will be taken to resolve the underlying condition(s). If...
- Disease classified as Ph+ B-ALL.
- Must be past the DLT period (Day 42).
- Platelet count \> 50,000/μL.
- ANC \> 1000/μL.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
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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.