CD19/CD22 CAR T-cell Therapy for B-cell Malignancies in Children and Young Adults
This study is testing a new type of cell therapy called CD19/CD22-CAR-transduced T cells for children and young adults (ages 3 to 39) with B-cell cancers like acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin lymphoma (B-NHL) that have come back or haven't responded to standard treatments. These CAR T cells are made from your own blood cells and are designed to target two specific proteins (CD19 and CD22) found on cancer cells. Before receiving the CAR T cells, you will get chemotherapy drugs called cyclophosphamide and fludarabine. The main goals are to see how safe this treatment is and how well it works to reduce or eliminate the cancer. The study is currently recruiting up to 130 participants, but its overall status is unclear.
- Study design
- This is an interventional study planning to enroll 130 participants. It is testing a specific cell therapy (CD19/CD22-CAR-transduced T cells) along with chemotherapy drugs.
- What's involved
- You would receive chemotherapy (cyclophosphamide and fludarabine) followed by an infusion of the CD19/CD22-CAR-transduced T cells. The specific number of visits or procedures is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked for 30 days after the CAR T infusion. The effectiveness of the treatment will be monitored monthly for the first 3 months, then every 6 months for up to 2 years after the infusion.
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NCT05442515
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
Recruiting
PHASE1Ages 3–39InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~130 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:CD19/CD22-CAR-transduced T cellscyclophosphamidefludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety
Measured over 30 days post CAR T infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Sara K Silbert, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis
Participant must:
Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and
Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and
Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and
Be unable to access (in a timely manner), ineligible for, or have relapsed/failed after or not responded to a commercially available CD19 CAR T-cell construct; and
Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.
CD22/CD19 expression
Cohorts A1b, B1b, C2b
CD19 must be detected on \>15% of the malignant cells by immunohistochemistry or \> 80% by flow cytometry.
CD22 positivity must be confirmed.
Cohorts D1b, 2 B-ALL
CD19 or CD22 positivity must be confirmed
Age \>= 3 years of age and \<=39 years of age at time of enrollment.
Clinical Performance status: Participants \>= 16 years of age: Karnofsky \>= 50%; Participants \< 16 years of age: Lansky scale \>= 50%.
Participants must have adequate organ and marrow function as defined below:
leukocytes \>= 750/mcL\*
platelets \>= 50,000/mcL\*
total bilirubin \<=2 X ULN (except in the case of participants with documented Gilbert's disease \> 3x ULN)
AST(SGOT)/ALT(SGPT) \<=10 X institutional upper limit of normal
creatinine \<= the maximum for age listed in the table below OR
measured creatinine clearance \>=60 mL/min/1.73 m\^2 for participants with creatinine levels above the max listed below per age.
Age (Years) \<= 5 / Maximum Serum Creatinine (mg/dL) \<= 0.8
Age (Years) 6 to \<= 10 / Maximum Serum Creatinine (mg/dL) \<= 1.0
Age (Years) \>10 / Maximum Serum Creatinine (mg/dL) \<= 1.2
a participant will not be excluded because of pancytopenia \>= Grade 3 if it is due to underlying bone marrow involvement by leukemia
Central nervous system (CNS) Status
Exclusion
Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.
Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding while on study therapy and until 1 month after the administration of CAR.
Cardiac function: Left ventricular ejection fraction \>= 45% or fractional shortening \>=28%
Pulmonary Function
Baseline oxygen saturation \>92% on room air at rest
Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.
Participants with CNS3 disease, progressing neurologic signs\* of CNS disease, radiologically detected active CNS lymphoma (\*resolving manifestation or persistent and/or irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)
Hyperleukocytosis (\>= 50,000 blasts/microL)
Positive serum or urine beta-HCG pregnancy test performed at screening.
Participants will be excluded based on prior therapy if they fail to meet following washout criteria:
Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies
Washout\*: \>=2 weeks
Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects
Therapy: Radiation
Washout\*: \>=3 weeks
Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable/evaluable disease outside the radiation window
Therapy: Allogeneic Stem Cell Transplant
Washout\*: \>= 100 days since SCT; \>= 30 days since completion of immunosuppression; \>= 6 weeks since donor lymphocyte infusion (DLI)
Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression
Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy
Washout\*: \> 30 days post infusion
Washout: Time between therapy and apheresis
Positive HIV antibodies consistent with active HIV.
Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current/active HCV/HBV.
Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.
History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.
Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.
What this trial measures
- Safety30 days post CAR T infusion
Assess the safety of administering escalating doses of autologous CD19/CD22-CAR engineered T cells in children and young adult with B cell ALL or lymphoma following a cyclophosphamide/fludarabine LD.
- EfficacyMonthly until 3 months post CAR T infusion and then at 6 months and every 6 months after that, for 2 years post-infusion for each participant, up to 2 years after the entry date of the last participant.
Determine the efficacy of CD19/CD22 therapy in participants with B-ALL/B-LBL.