Phase 2 Trial of CD19 Redirected Autologous T Cells

  • STATUS
    Recruiting
  • End date
    Mar 10, 2035
  • participants needed
    81
  • sponsor
    University of Pennsylvania
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Updated on 16 February 2024
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Summary

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).

Details
Condition Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL, Infants With Very High Risk KMT2A B-ALL, Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation
Age 29years or below
Treatment Murine CART19
Clinical Study IdentifierNCT04276870
SponsorUniversity of Pennsylvania
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed informed consent form must be obtained prior to any study procedure
Male and female patients with documented CD19+ B-ALL
a.Cohort A & B: Patients, regardless their response to initial or relapsed B
ALL therapy, with the following characteristics: i.Cohort A: Subjects with
confirmation of a hypodiploid karyotype (chromosome number fewer than 45)
ii.Cohort B: Subjects with cytogenetic confirmation of the chromosomal
translocation t(17;19) (Cohort B) b.Cohort C: Infants w/ newly diagnosed KMT2A
rearranged B-ALL classified as very high risk by the following criteria: i.Age
< 3 months at diagnosis ii.Age < 6 months and WBC > 300,000x109/L at diagnosis
or a poor prednisone response in induction iii.MRD positive > 0.01 (or PCR >
) after 2 courses of standard infant ALL therapy
c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with
cranial XRT or HSCT for the current relapse
\. Expression of CD19 on leukemic blasts demonstrated by flow cytometry of
bone marrow, cerebrospinal fluid, or peripheral blood
\. Age 0 to 29 years
\. Adequate organ function defined as
A serum creatinine based on age/gender as follows
Maximum Serum Creatinine (mg/dL) Age Male Female 0 to < 2 years 0.6 0.6 2 to <
years 0.8 0.8 6 to < 10 years 1.0 1.0 10 to < 13 years 1.2 1.2 13 to < 16
years 1.5 1.4
years 1.7 1.4
\. Adequate liver function
i.ALT 5 x ULN; ALT ii.Total bilirubin 3 x ULN iii.ALT and/or bilirubin results
that exceed this range are acceptable if, in the opinion of the physician-
investigator (or as confirmed by liver biopsy), the abnormalities are directly
related to ALL infiltration of the liver
c.Must have a minimum level of pulmonary reserve defined as Grade 1 dyspnea
and < Grade 3 hypoxia; DLCO 40% (corrected for anemia) if PFTs are clinically
appropriate as determined by the physician-investigator
d.Left Ventricular Shortening Fraction (LVSF) 28%, or Left Ventricular
Ejection Fraction (LVEF) 45% by echocardiogram. In cases where quanitative
assessment of LVSF/LVEF is not possible, a statement by the cardiologist that
the ECHO shows qualititatively normal ventricular function wll suffice
\. Adequate performance status defined as Lansky or Karnofsky score 50
\. Subjects of reproductive potential must agree to use acceptable birth
control methods

Exclusion Criteria

For subjects with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion
Active hepatitis B or active hepatitis C
HIV Infection
Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy
Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well
CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
Pregnant or nursing (lactating) women
Uncontrolled active infection
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