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New treatment option for Leukemia, Lymphocytic, Chronic, B-Cell
Official title Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias
ClinicalTrials.gov ID: NCT06364423
What this study is testing
What is Autologous HuCD19 ( Anti-CD19)CAR T cells?
Autologous HuCD19 ( Anti-CD19)CAR T cells is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for leukemia, lymphocytic, chronic, b-cell.
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
- Background: Chronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Malignancy criteria
- Histologically confirmed participants with either CLL or SLL or B-cell acute lymphoblastic leukemia or lymphoma (ALL) via immunohistochemical or flow...
- Demonstration of CD19 expression on CLL/SLL or ALL, as assessed by the NCI Laboratory of Pathology or NIH Department of Laboratory Medicine...
- CD19 expression must be uniform meaning no populations of clearly CD19-negative CLL/SLL, Richter s or ALL cells are observed.
- CD20 must be detected on \>= 20% of malignant cells by flow cytometry or immunohistochemistry. Documentation of CD20 expression is not required for...
You likely can't join if
- Participants who are receiving any other investigational agents.
- Participants who have had prior CAR T-cell therapy.
- Participants who have had a live-attenuated or viral vector-based vaccine in the last 60 days prior to pre-leukapheresis rituximab. Participants who...
- Participants that require urgent therapy due to tumor mass effects or spinal cord compression.
- Current/active HIV infection, as measured by seropositivity for HIV antibody.
- Participants with second malignancies in addition to their CLL or ALL are not eligible if the second malignancy has required treatment with surgery...
See the full eligibility criteria
Who can join
- Malignancy criteria
- Histologically confirmed participants with either CLL or SLL or B-cell acute lymphoblastic leukemia or lymphoma (ALL) via immunohistochemical or flow cytometry methods will be eligible. Participants with evidence of...
- Demonstration of CD19 expression on CLL/SLL or ALL, as assessed by the NCI Laboratory of Pathology or NIH Department of Laboratory Medicine Hematopathology section. For participants with pathologically confirmed Richter...
- CD19 expression must be uniform meaning no populations of clearly CD19-negative CLL/SLL, Richter s or ALL cells are observed.
- CD20 must be detected on \>= 20% of malignant cells by flow cytometry or immunohistochemistry. Documentation of CD20 expression is not required for patients who have received CD20-directed therapy within 90 days prior...
- The last dosage of systemic therapy (including corticosteroids) must be at least 14 days prior to the first dose of rituximab, with the exceptions of BTK inhibitors (BTKi) for CLL/SLL and tyrosine kinase inhibitors...
- For participants who have received antibodies targeting CD19, at least sixty days must elapse between therapy with antibodies targeting CD19 and CAR T-cell infusion.
- Participants with CLL/SLL must have received at least two prior treatment regimens, at least one of which must have contained a Bruton s tyrosine kinase (BTK) inhibitor. Participants who took a BTK inhibitor but stopped...
- Participants with refractory ALL that failed induction or participants with relapsed ALL after a standard induction regimen or after any later line of therapy are eligibleParticipants with relapsed or refractory ALL...
- All participants must have measurable malignancy as defined by at least one of the criteria below.
- Presence of CLL,SLL, or ALL masses that are measurable (minimum 1.5 cm in largest diameter) by CT scan or PET/CT is required unless bone marrow or blood involvement with malignancy is detected.
- For CLL/SLL or ALL with only bone marrow and/or blood involvement, no mass is necessary, but if a mass is not present, bone marrow and/or blood malignancy must be detectable by flow cytometry. Any level of CLL/SLL or...
- Other
- Age \>= 18 years.
- Performance status (ECOG) 0-1.
- Participants must have adequate organ and marrow function as defined below:
- ANC \>= 1,000/mcL without the support of filgrastim or other growth factors in the 10 days prior to screening assessment
- platelets \>= 50,000/mcL without transfusion support
- hemoglobin \>= 8 g/dL
- total bilirubin \<= 2.0 mg/dL
- ALT or AST Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST...
- Serum Creatinine Serum creatinine levels \ = 1.5 X institutional ULN may participate if serum creatinine eGFR is \>=50 mL/min/1.73m\^2 by 2021 CKD-EPI equation.
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);
- AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- (A)Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.
- For CLL participants, B cells must make up less than 95% of blood lymphocytes on a lymphocyte phenotyping profile TBNK at the time of screening assessment. For ALL participants, the peripheral blood blast percentage on...
- Room air oxygen saturation of 92% or greater
- Participants of child-bearing or child-fathering potential must be willing to practice abstinence or highly effective contraception starting at the time of study entry, for the duration of study therapy, and for 12...
- Participants must agree not to donate eggs for 12 months after receiving the protocol treatment
- Participants who are breastfeeding must be willing to cease breastfeeding from study treatment initiation through 12 months after the last dose of the study drugs.
- Participants must have a negative blood PCR test for hepatitis B DNA. If hepatitis B DNA (PCR) testing is not available, participants must have a negative hepatitis B surface antigen and negative hepatitis B core...
- Participants must have a negative blood PCR test for hepatitis C RNA. Only if Hepatitis C PCR testing is not available in a timely manner, participants must have a negative Hepatitis C antibody test.
- Cardiac ejection fraction of greater than or equal to 50% by echocardiography and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 30 days prior to treatment...
- All participants must have the ability to understand and willingness to sign a written informed consent.
- All participants must be willing to undergo mandatory biopsies during the study.
What rules you out
- Participants who are receiving any other investigational agents.
- Participants who have had prior CAR T-cell therapy.
- Participants who have had a live-attenuated or viral vector-based vaccine in the last 60 days prior to pre-leukapheresis rituximab. Participants who plan to receive a live attenuated or viral vector-based vaccine within...
- Participants that require urgent therapy due to tumor mass effects or spinal cord compression.
- Current/active HIV infection, as measured by seropositivity for HIV antibody.
- Participants with second malignancies in addition to their CLL or ALL are not eligible if the second malignancy has required treatment with surgery, radiation or chemotherapy, or other therapies within the past 2 years...
- Positive beta Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in women of childbearing potential (WOCBP) performed at screening.
- Active uncontrolled systemic infections (defined as infections causing fevers within 48 hours of the date of planned protocol rituximab or chemotherapy start and infections requiring intravenous antibiotics when...
- Active coagulation disorders, major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of...
- Significant neurologic disorders, including a history of a seizure disorder as an adult, that are not completely and permanently resolved and not requiring current treatment.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) that has not been cured by a prior allogeneic stem cell transplant.
- For participants that have not had prior allogeneic stem cell transplant: Systemic corticosteroid steroid therapy of any dose greater than 5 mg/day or more of prednisone or equivalent is not allowed within 14 days prior...
- For participants that have had prior allogeneic stem cell transplant: Receiving any systemic immunosuppressive drugs including corticosteroids at doses of greater than 5 mg/day prednisone or equivalent within 28 days...
- History of severe immediate hypersensitivity reaction to any of the agents used in this study, including hypersensitivity to aminoglycoside antibiotics, which may be used in the cell culture media.
- Participants with CNS3 disease, neurologic signs of CNS disease, radiologically detected active CNS lymphoma or meningeal involvement.
- Checkpoint inhibitor drugs such as pembrolizumab or nivolumab or other antibodies targeting PD-1 or PDL-1 within 180 days of pre-leukapheresis rituximab. This is because of possible effects checkpoint inhibitor therapy...
- Known active alcohol or drug abuse.
- History of allergy to study drug components.
- Active tumor lysis syndrome as assessed by serum uric acid, LDH, calcium, and phosphorus.
- Active rhabdomyolysis as assessed by elevated CK and acute change in renal function as reflected by increased creatinine and blood urea nitrogen (BUN).
- Active diabetic ketoacidosis or hyperosmolar hyperglycemic state, as assessed by serum glucose. The urine will be tested for ketones if serum glucose is over 350 mg/dL at screening.
- Participants who received a previous allogeneic HSCT must have no (grade 0) acute GVHD (Appendix H) and either no chronic GVHD or mild chronic GVHD. Participants with GVHD meeting the above criteria with local therapy...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. 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.