RecruitingPhase 1

CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL

Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and/or Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Months to 30 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This trial will enroll up to 53 patients with 21 patients in each cohort receiving treatment with lymphodepleting chemotherapy followed by CD19x22 CAR T cell infusion, with a total of up to 42 treated patients overall."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of CD19x22 CAR T-cell therapy, which uses changed immune cells to target CD19 and CD22 on cancer cells. It is for people ages 3 months to 30 years with B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer, that has come back or has not responded to treatment.

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 3 months to 30 years old when joining the study.
  • Have B-ALL that has returned at least twice, returned after a donor bone marrow transplant, or returned or resisted treatment after CAR T therapy aimed at one target. You may also qualify if standard treatment has failed or you or your parents prefer CAR T therapy over a bone marrow transplant.
  • Have CD19, CD22, or both markers on cancer cells at the latest check of cancer that returned or resisted treatment.
  • Meet the study’s score for ability to do daily activities: Lansky or Karnofsky score of at least 50, or ECOG score of 2 or less.
  • Be able to have white blood cells collected, or have properly stored cells already collected. If you had CAR T therapy before, wait at least 90 days after that treatment before cell collection.
  • Not be pregnant or breastfeeding.
  • Have a signed consent form from you, a parent or guardian, or a legally authorized representative, as required, after routine screening tests.
  • Be willing to follow study steps, stay available during the study, and take part in long-term follow-up.

Who can't join

  • Have uncontrolled leukemia in the brain or spinal cord that is getting worse despite treatment or is causing symptoms.
  • Before blood cell collection, have had a donor stem cell transplant less than 100 days ago, active graft-versus-host disease needing whole-body treatment, or a donor immune cell infusion less than 6 weeks ago. Graft-versus-host disease is when donor cells attack your body.
  • Have an uncontrolled, life-threatening infection that the doctor believes would make cell collection or study treatment unsafe.
  • Have severe lung, heart, liver, or kidney problems based on the study’s tests.
  • Be able to become pregnant or father a child but unwilling to use birth control from enrollment until 12 months after study treatment.
  • Have known HIV infection or active hepatitis B or C infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

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