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New treatment option for Precursor Cell Lymphoblastic Leukemia-Lymphoma
Official title Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
ClinicalTrials.gov ID: NCT06709469
What this study is testing
What is Autologous CD19/CD22 CAR T cells?
Autologous CD19/CD22 CAR T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for precursor cell lymphoblastic leukemia-lymphoma.
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 goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are: 1.
- 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 up to 30
You may be able to join if
- ARM A: CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy...
- ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.
- Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete...
- For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).
- Lansky (age \<16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
You likely can't join if
- Enrolled in another clinical trial in the previous 4 weeks.
- Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV...
- Any of the following cardiac criteria: cardiac echocardiography with LVSF\<30% or LVEF\<40%; or clinically significant pericardial effusion.
- Presence of CNS-3 disease or uncontrolled seizure disorder.
- Active immunosuppressive therapy with the exception of prednisone 10 mg/day (or equivalent), within 7 days prior to enrolment.
- GFR \ 3 times the upper limit of normality (unless due to Gilbert's syndrome).
See the full eligibility criteria
- ARM A: CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not...
- ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.
- Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option.
- For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).
- Lansky (age \<16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
- Life expectancy greater than 12 weeks.
- Absolute neutrophil count (ANC) ≥ 500/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.
- Platelet count ≥ 50,000/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.
- Absolute lymphocyte count ≥ 100/μL.
- Adequate renal, hepatic, pulmonary, and cardiac function.
- Adequate venous access and absence of contraindications for lymphoapheresis
- Patients with a seizure disorder may be enrolled if well controlled with anticonvulsants.
- Patients or patients' legal representative, parent(s), or guardian able to provide written informed consent.
- Enrolled in another clinical trial in the previous 4 weeks.
- Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus.
- Any of the following cardiac criteria: cardiac echocardiography with LVSF\<30% or LVEF\<40%; or clinically significant pericardial effusion.
- Presence of CNS-3 disease or uncontrolled seizure disorder.
- Active immunosuppressive therapy with the exception of prednisone 10 mg/day (or equivalent), within 7 days prior to enrolment.
- GFR \ 3 times the upper limit of normality (unless due to Gilbert's syndrome).
- Any other condition that, in the opinion of the PI, may interfere with the how well it works and/or safety evaluation of the trial.
- Pregnant or lactating women.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests. Male...
- Sexually active males should use a condom during intercourse for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
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 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. 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.