NCT05442515RecruitingPhase 1/2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Phase 1/2 Dose Escalation Study of CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 130 (estimated)
First submitted: 1 Jul 2022
Start date: 28 Dec 2022
Primary completion date: 1 Jul 2027
Lead sponsor: National Cancer Institute (NCI)
Diseases: Acute lymphoblastic leukaemia, Chronic lymphocytic leukaemia, Childhood cancers
NCT number: NCT05442515

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 130
From 28 Dec 2022 to the primary completion date, 1 Jul 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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)
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.

Other illness

Positive HIV antibodies consistent with active HIV.
Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current/active HCV/HBV.
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.

Lab values

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

Other

Participants meeting any of the following criteria are not eligible for participation in the study:
Hyperleukocytosis (\>= 50,000 blasts/microL)

Criteria the registry did not label

INCLUSION CRITERIA:
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
Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria
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.

Age in the registry: 3 years to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.