New CAR T-cell therapy for pediatric B-ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of a novel bispecific CAR T-cell therapy targeting both CD19 and CD22 in children with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). The therapy aims to address the limitations of current CD19-targeted treatments, particularly in patients who have experienced CD19-negative relapses. By utilizing a bispecific approach, the study seeks to improve treatment outcomes for pediatric patients who have not responded to standard therapies. Participants will undergo leukapheresis to collect T-cells, which will then be modified to express the bispecific CAR before being reinfused into the patient.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must have a history of B precursor ALL with any of the following conditions:

   1. Relapsed two or more times.
   2. Relapsed at any time after allogeneic bone marrow transplant (BMT).
   3. Relapse or refractory after single antigen targeting CAR T cell therapy.

   i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
2. CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
3. Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
4. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
5. Males OR non-pregnant, non-lactating females.
6. Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
7. Provision of a signed and dated consent form from parent or guardian (patients \< 18), the patient themselves (\> 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
8. Stated willingness to comply with all study procedures and be available for the duration of the study.
9. Willingness to participate in long-term follow-up protocol.

Exclusion Criteria:

1. Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
2. History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:

   1. Less than 100 days post-transplant;
   2. Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
   3. Less than 6 weeks post donor lymphocyte infusion (DLI).
3. Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.
4. Evidence of severe organ dysfunction defined by:

   1. Baseline oxygen saturation of \< 90% on room air
   2. Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
   3. Transaminases \> 10x upper limit of normal (ULN) or bilirubin \> 5x the ULN, unless thought to be related to primary disease
   4. Estimated Creatinine (Cr) clearance \< 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
5. Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product
6. Known HIV infection or active Hepatitis B or Hepatitis C infection.

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Vanessa Fabrizio, MD — University of Colorado, Denver
• Study coordinator: Vanessa Fabrizio, MD
• Email: BMT@childrenscolorado.org
• Phone: 720-777-6860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

• Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL

  This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.

  Recruiting Phase 1 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07838714

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL

  This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575971

• CD22/CD19 CAR-T consolidation for adults with standard-risk B-ALL

  This study will try dual-target CD22/CD19 CAR-T cell therapy as a consolidation treatment for adults with standard-risk B-cell acute lymphoblastic leukemia who are in first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575919

• Fludarabine dosing for children and young adults with B-cell acute lymphoblastic leukemia

  This trial will test whether pharmacokinetic (PK)-targeted fludarabine dosing before tisagenlecleucel CAR T-cell therapy helps children and young adults with relapsed or refractory B‑cell ALL more than standard fludarabine dosing.

  Recruiting at 7 sites Phase 3 Memorial Sloan Kettering Cancer Center · New York, New York and 7 other locations · NCT07223021

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.