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New treatment option for Leukemia
Official title Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
ClinicalTrials.gov ID: NCT06408194
What this study is testing
What is CD22CART infusion?
CD22CART infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leukemia.
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
- The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
- 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 1 to 25
You may be able to join if
- Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
- Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later...
- CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of...
- Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.
- Performance Status: Participants \> 16 years of age: Karnofsky ≥ 50%; Participants ≤ 16 years of age: Lansky scale ≥ 50%.
You likely can't join if
- May not have Human Immunodeficiency Virus (HIV)/Hepatitis B (HBV) or Hepatitis C (HCV infection) or uncontrolled, symptomatic, intercurrent illness.
- May not have hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would...
- May not have severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in...
- May not have active CNS disorder, or history of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease...
- May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic...
See the full eligibility criteria
- Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
- Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse)
- CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of expression will be acceptable, as that is the standard for commercial...
- Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.
- Performance Status: Participants \> 16 years of age: Karnofsky ≥ 50%; Participants ≤ 16 years of age: Lansky scale ≥ 50%.
- Normal Organ and Marrow Function
- Absolute Neutrophil Count (ANC) ≥ 750/uL\
- Platelet count ≥ 50,000/uL\
- Absolute Lymphocyte Count ALC \> 150/uL\
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Baseline oxygen saturation \> 92% on room air
- Creatinine within ULN for age or Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
- Total bilirubin ≤ 1.5 mg/dl, except in Participants with Gilbert's syndrome. [Elevations related to leukemia involvement of the liver will not disqualify a subject]
- Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) ≤ 10 x ULN (except in Participants with liver involvement by leukemia)
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.
- if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it...
- Participants with Central Nervous System (CNS) involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity
- Participants who have undergone autologous SCT with disease progression or relapse following SCT are eligible. Participants with history of allogeneic SCT must be at least 100 days from SCT, have no evidence of Graft...
- Females of child bearing potential and males of child fathering potential must be willing to practice birth control during and for 4 months post chemotherapy or for as long as Chimeric Antigen Receptor (CAR) T cells are...
- Females of child bearing potential must have negative pregnancy test.
- Must meet wash out period since prior therapies according to commercial KYMRIAH® (tisagenlecleucel) SOPs.
- Must have recovered from acute side effects from prior therapy to meet eligibility.
- If had prior CAR therapy, will be eligible if at least 30 days has elapsed prior to apheresis.
- Ability to give informed consent. All Participants ≥ 18 years of age must be able to give informed consent. For participants \ 7 years of age, when appropriate. If a minor becomes of age during participation of this...
- A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.
- May not have Human Immunodeficiency Virus (HIV)/Hepatitis B (HBV) or Hepatitis C (HCV infection) or uncontrolled, symptomatic, intercurrent illness.
- May not have hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
- May not have severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.
- May not have active CNS disorder, or history of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease with 12 months of enrollment.
- May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
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, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, 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.