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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Co-administration of CART22-65s and huCART19 for B-ALL
ClinicalTrials.gov ID: NCT05674175
What this study is testing
What is Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)?
Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s) is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Also referred to as CART22-65s.
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 study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).
- 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 up to 29
You may be able to join if
- Signed informed consent form
- Patients with documented CD19+ and/or CD22+ ALL/LLy:
- Cohort A: Patients with relapsed or refractory ALL/LLy:
- Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
- Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
You likely can't join if
- Active hepatitis B or active hepatitis C
- HIV infection
- Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
- Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's...
- Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of...
- Pregnant or nursing (lactating) women
See the full eligibility criteria
- Signed informed consent form
- Patients with documented CD19+ and/or CD22+ ALL/LLy:
- Cohort A: Patients with relapsed or refractory ALL/LLy:
- Cohort B: Patients with poor response to prior B cell directed engineered cell therapy
- Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy
- Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a...
- Age 0-29 years
- Adequate organ function
- Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
- people of reproductive potential must agree to use acceptable birth control methods.
- Active hepatitis B or active hepatitis C
- HIV infection
- Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
- Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or...
- Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.
- Pregnant or nursing (lactating) women
- Uncontrolled active infection
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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, up to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.