A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04571138
Collaborator
(none)
42
Enrollment
5
Locations
1
Arm
208.2
Anticipated Duration (Months)
8.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: SCRI-CAR22v2
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
Actual Study Start Date :
Sep 25, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Feb 1, 2038

Arms and Interventions

ArmIntervention/Treatment
Experimental: SCRI-CAR22v2

Patients will receive SCRI-CAR22v2 in either Phase I or Phase II

Biological: SCRI-CAR22v2
Single infusion of SCRI-CAR22v2

Outcome Measures

Primary Outcome Measures

  1. he adverse events associated with CAR T cell product infusions will be assessed [28 days post-infusion]

    The type, frequency, severity, and duration of adverse events will be summarized

  2. The ability to successfully manufacture SCRI-CAR22v2 [28 days]

    We will measure the number of successfully manufactured SCRI-CAR22v2 products

  3. The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed [28 days post-infusion]

    The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years

  • Evidence of refractory or recurrent CD22+ leukemia or lymphoma

  • Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.

  • Life expectancy ≥ 8 weeks

  • Lansky or Karnofsky, as applicable, score ≥ 50

  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells

  • ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy

  • ≥ 7 days post last corticosteroid therapy

  • ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use

  • ≥ 1 day post hydroxyurea

  • 30 days post most recent CAR T cell infusion

  • Adequate organ function

  • Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL

  • Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial

  • Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria:
  • Presence of active malignancy other than disease under study

  • History of symptomatic CNS pathology or ongoing symptomatic CNS pathology

  • CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion

  • Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy

  • For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment

  • Presence of active severe infection,

  • Presence of primary immunodeficiency syndrome

  • Subject has received prior virotherapy

  • Pregnant or breastfeeding

  • Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered

  • Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Children's Hospital Los AngelesLos AngelesCaliforniaUnited States90027
2Children's National HospitalWashingtonDistrict of ColumbiaUnited States20010
3Riley Hospital for ChildrenIndianapolisIndianaUnited States46202
4Texas Children's HospitalHoustonTexasUnited States77030
5Seattle Children's HospitalSeattleWashingtonUnited States98105

Sponsors and Collaborators

  • Seattle Children's Hospital

Investigators

  • Study Chair: Corinne Summers, MD, Seattle Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebecca Gardner, Associate Medical Director, Immunotherapy Coordinating Center, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT04571138
Other Study ID Numbers:
  • PLAT-07
First Posted:
Sep 30, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022