TRICAR-ALL: CAR-T Cell Therapy for B-Cell Leukemia
This study is testing a new type of cell therapy called Autologous TRICAR-ALL T-cells for children and young adults (ages 1 to 25) with B-cell Acute Lymphoblastic Leukemia (ALL) that has returned or not responded to previous treatments. This therapy uses your own infection-fighting T cells, which are specially modified in the lab to target and kill cancer cells. Before receiving the TRICAR-ALL T-cells, you will get chemotherapy (Fludarabine and Cyclophosphamide). The main goal of this study is to find a safe dose of TRICAR-ALL T-cells and see how well patients tolerate the treatment. The study is currently recruiting and plans to enroll 38 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It will evaluate different dose levels of TRICAR-ALL T-cells in about 38 participants.
- What's involved
- You will receive chemotherapy for several days, followed by an injection of TRICAR-ALL T-cells. You will be monitored for at least 4 weeks after the injection and must remain locally during this time.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main safety outcome is measured within 28 days of the TRICAR-ALL T cell infusion. If you have a complete response after 4 weeks, you may proceed to a bone marrow transplant and leave the treatment portion of the study.
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NCT05010564
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
Recruiting
PHASE1Ages 12–25InterventionalTreatmentBaylor College of MedicineInvestigator-initiated
~38 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT) rate by CTCAE v5.0
Measured over within 28 days of the TRICAR-ALL T cell infusion.
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Bahey Salem, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
- Nabil Ahmed, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
- Meenakshi Hegde, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
Age between 1 and 25 years.
Life expectancy of ≥ 8 weeks
Weight ≥ 10 kg
Subjects ≥ 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for subjects \< 18 years of age. Assent will be obtained from pediatric subjects and according to applicable regulatory and local institutional requirements. Adults with cognitive impairment who are unable to consent and those with Down's syndrome are also eligible for this protocol with consent/assent according to applicable regulatory and local institutional requirements.
The subject must discontinue all anti-cancer agents and, in the opinion of the investigator, has recovered from significant acute toxic effects of: a) Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to collection, with the exception of intrathecal chemotherapy and maintenance chemotherapy being discontinued ≥ 72 hours prior to collection (for the subset of subjects who relapse during maintenance); b) Steroid use: All systemic corticosteroid therapy (unless physiologic replacement dosing of ≤ 12mg/m2/day hydrocortisone or equivalent) must be discontinued ≥ 3 days prior to collection; c) Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to collection; d) Hydroxyurea: must be discontinued ≥ 1 day prior to collection; e) Prior CAR-T cell therapy: must be at least 30 days from most recent CAR-T cell infusion prior to collection; f) Immunotherapy directed at leukemia: No antibodies within three (3) half-lives prior to collection (or within 4 weeks) whichever is shorter. This includes Antithymocyte globulin (ATG) formulations; g) Anti T-cell Antibodies, Alemtuzumab: must be discontinued ≥ 8 weeks prior to collection
Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22 and meeting any of the following conditions:
B-ALL with no prior history of allo-HCT with one of the following:
B-ALL recurrent after allo-HCT defined as having ≥ 0.01% marrow disease
Available transduced T-cells with ≥ 15% expression of CD19, CD20 or CD22 CAR by flow cytometry.
Prohibited medications - washout periods (prior to CAR-T cell product infusion): Radiation therapy including TBI and cranial radiation. Local/palliative radiation excluded: ≥ 4 weeks. Cytotoxic chemotherapy: ≥ 2 days. Tyrosine Kinase Inhibitors: ≥ 7 days
Total Bilirubin: ≤ 3X upper limit of normal (ULN) for age OR conjugated bilirubin ≤ 2mg/dl, except in subjects with Gilbert's syndrome where a total bilirubin level of up to 5.3 mg/dL will be acceptable
ALT ≤ 5 times upper limit of normal
Adequate renal function defined as serum creatinine that is ≤ maximum based on age/gender (as indicated below) or Creatinine clearance or GFR (as measured or estimated by Cockcroft Gaultor Schwartz) ≥ 50 mL/min/1.73m2
Pulse oximetry of ≥ 90% on room air
Left ventricular fractional shortening (LVFS) ≥ 28% confirmed by echocardiogram or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram (MUGA or MRI heart may replace echocardiogram).
Lansky score of ≥ 50% (age ≥1 and \< 16 years) or Karnofsky score of ≥ 50% (age ≥ 16 years). Refer to appendix IV
Donor lymphocyte infusions (DLI) completed \> 6 weeks prior to CAR-T cell infusion
Subjects of childbearing/fathering potential must agree to use highly effective contraception (see Appendix IIII for acceptable forms of contraception) from the time of initial T cell infusion through 12 months following the last T cell infusion
Subjects \> 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for subjects \< 18 years of age. Assent will be obtained from pediatric subjects and according to applicable regulatory and local institutional requirements. Adults with cognitive impairment who are unable to consent and those with Down's Syndrome are also eligible for this protocol with consent/assent according to applicable regulatory and local institutional requirements.
Exclusion
Active malignancy other than disease under study
Presence of active severe infection, defined as: a) positive blood culture within 48 hours of collection, OR; b) known history of active viral infections including infection with HIV, hepatitis B, hepatitis C or HTLV
Primary immunodeficiency syndrome
Pregnant or breastfeeding
Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Pregnant or lactating
Presence of any condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy.
If history of allogeneic Hematopoietic Cell transplantation (allo-HCT):
active GVHD: acute GVHD \>/= Grade 2 or chronic GVHD, extensive global severity score, OR
actively taking corticosteroids for management of GVHD at a dose of \> 0.5 mg/kg/day of prednisone equivalent
receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to T-cell infusion.
Acute symptomatic CNS pathology requiring active medical intervention, including paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder. Subjects with chronic, stable neurological conditions such as non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 3 months may be eligible. Subjects with a history of an isolated seizure episode of ≥ 4 weeks (including methotrexate neurotoxicity) without an underlying epileptic disorder are eligible.
What this trial measures
- Dose-limiting toxicity (DLT) rate by CTCAE v5.0within 28 days of the TRICAR-ALL T cell infusion.
Toxicity for all patients will be evaluated using the NCI common toxicity criteria scale, version 5.0 (https://ctep.cancer.gov) with the exception of CRS and neurological toxicities which will be evaluated based on the ASTCT Consensus Guidelines (Lee et al, BBMT 2019).