Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-25
SponsorStanford University
About this trial
The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse)
CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of expression will be acceptable, as that is the standard for commercial KYMRIAH® (tisagenlecleucel) and the optimal level of CD22 expression is not well defined.
Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.
Disqualifiers
May not have Human Immunodeficiency Virus (HIV)/Hepatitis B (HBV) or Hepatitis C (HCV infection) or uncontrolled, symptomatic, intercurrent illness.
May not have hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
May not have severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.
May not have active CNS disorder, or history of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease with 12 months of enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
CD22CART infusion
DrugCD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.
Tisagenlecleucel
DrugAll enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: LymphodepletionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The number of patients who experience dose limiting toxicities (Phase 1)
The number of patients who experience dose limiting toxicities within 28 days of administration of CD22 CART when given within 28-42 days of infusion of tisagenlecleucel
Time frame
28 days after single infusion of CD22 CAR T cells2
The number of patients who successfully receive infusion of CD22CART (Phase 1b)
The number of patients who successfully receive infusion of CD22CART within 42 days of infusion of tisagenlecleucel
Time frame
within 42 days of infusion of tisagenlecleucelSecondary outcomes
1
Number of patients who have no evidence of leukemia
Number of patients who have no evidence of leukemia (complete response or complete response with incomplete count recovery) at Day 28 following CD22 CART infusion.
Time frame
28 days after single infusion of CD22 CAR T cells2
The number of patients who have B cell aplasia
The number of patients who have B cell aplasia 6 months following tisagenlecleucel and CD22 CART infusion
Time frame
6 months following single infusion of CD22 CAR T cells and tisagenlecleucelSponsors and contacts
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Source ClinicalTrials.gov