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New treatment option for B-NHL
Official title CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
ClinicalTrials.gov ID: NCT05442515
What this study is testing
What is CD19/CD22-CAR-transduced T cells?
CD19/CD22-CAR-transduced T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-nhl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 39
You may be able to join if
- 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...
- Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia...
- Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and
You likely can't join if
- Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12...
- Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding while on study therapy and until 1 month...
- 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.
See the full eligibility 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...
- 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 \ = 50%.
- Participants must have adequate organ and marrow function as defined below:
- leukocytes \>= 750/mcL\
- platelets \>= 50,000/mcL\
- total bilirubin \ 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
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.