CD19-directed CAR T cells with IL-7Rα signaling for children with relapsed or refractory B-cell 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 is a Phase 1, multi-center effort to use autologous T cells genetically modified to express a CD19-directed chimeric antigen receptor that includes IL-7Rα signaling for pediatric patients with relapsed or refractory B-cell ALL. Patients will have their T cells collected, engineered and expanded, and then reinfused with close monitoring for safety and early signs of anti-leukemia activity. The study focuses on safety endpoints and early efficacy signals in children treated at major Thai hospitals. Investigators will monitor for known CAR-T toxicities and measure remission rates and short-term survival outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have relapsed, or refractory ALL treated with at least one lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.

   \- Participant with Philadelphia Chromosome positive ALL are eligible if the progressed, had stable disease or relapsed after one line of therapy including tyrosine kinase inhibitors (TKIs)
2. The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis
3. Age 1 - 18 years
4. Sex: Male or Female
5. Performance status: Lansky or Karnofsky score greater than or equal to 50
6. Normal organ function:

   * AST (SGOT) less 5 times the upper limit of normal (ULN)
   * ALT (SGPT) less 5 times the upper limit of normal (ULN)
   * Total bilirubin less 3 times the upper limit of normal (ULN)
   * Creatinine less 5 times the upper limit of normal (ULN)
   * SpO2 room air greater than or equal to 90%
7. Prior therapy wash-out before planned leukapheresis 7.1 Greater than or equal to 7 days post last chemotherapy/biologic therapy administration 7.2 Three half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy 7.3 At least 30 days from most recent cellular infusion 7.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed
8. Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

1. Active GVHD that required systemic immunosuppressant with 4 weeks of enrollment
2. History of active malignancy other than non-melanoma skin cancer and carcinoma in situ (e.g. cervix, bladder, breast).
3. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, Graft Versus Host Disease or psychiatric illness/social situations that would limit compliance with study requirements.
4. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with potential for teratogenic or abortifacient effect. Women of child bearing potential must have negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of mother with CAR-T cells, breast feeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving CAR-T cell infusion.
5. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
6. Serologic status reflecting active HIV, hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment.
7. Participants who have a history of anaphylactic reaction to albumin.

Where it's running

• King Chulalongkorn Memorial Hospital
  Bangkok, Pathumwan, Thailand Recruiting
• Siriraj Hospital
  Bangkok, Bangkoknoi, Thailand Not yet recruiting
• Maharaj Nakorn Chiang Mai Hospital
  Chiang Mai, Mueang Chiang Mai District, Thailand Not yet recruiting

Study contacts

• Principal investigator: Kanhatai Chiengthong, MD — King Chulalongkorn Memorial Hospital
• Study coordinator: Piti Techavichit, Associate Professor, MD
• Email: piti.t@chula.ac.th
• Phone: +66817515363

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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.