CART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB for B-Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
B-Cell Lymphoma+1 MoreCART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB - Biological
Eligibility
1 - 24
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment for kids with leukemia that has relapsed or is resistant to other treatments.

Eligible Conditions
  • B Cell Leukemia
  • B-Cell Lymphoma

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From date of dosing ( day 1 ) up to 50 weeks

Week 50
Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS)
Week 50
Evaluate overall response rate including complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
at 50 weeks
Evaluate duration of remission (DOR)
at Day 28
Evaluate Overall Complete Remission Rate (ORR)

Trial Safety

Trial Design

1 Treatment Group

CART22 cells
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: CART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB · No Placebo Group · Phase 1

CART22 cells
Biological
Experimental Group · 1 Intervention: CART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of dosing ( day 1 ) up to 50 weeks

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,841 Previous Clinical Trials
41,126,401 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
650 Previous Clinical Trials
7,849,553 Total Patients Enrolled
Stephan Grupp, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
81 Total Patients Enrolled

Eligibility Criteria

Age 1 - 24 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
2nd or greater relapse of leukemia, any marrow relapse after allogeneic HSCT and ≥ 6 months from SCT infusion, any marrow relapse after CAR-modified T cell therapy, refractory disease defined as having not achieved a CR after > 2 chemotherapy regimens, Ph+ ALL patients intolerant to or failed tyrosine kinase inhibitor therapy
-A person with ALL must have ALT levels below 500 U/L, bilirubin levels below 3x the upper limit of normal, and a minimum level of pulmonary reserve (defined as ≤ Grade 1 dyspnea, pulse oxygen > 92% on room air; DLCO > 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the treating investigator)
Maximum serum creatinine (mg/dL) levels for males and females aged 1 to less than 2, 2 to less than 6, 6 to less than 10, 10 to less than 13, 13 to less than 16, and 16 years and older.
Before any study procedures take place, a signed informed consent form must be obtained from each participant.
This text documents CD22 tumor expression in bone marrow or peripheral blood by flow cytometry at relapse.
The patient's marrow will be assessed for evidence of disease by standard morphologic or by MRD criteria
People aged between 1 and 29 years old.
Subjects who could potentially procreate must agree to use acceptable birth control methods.
You have an adequate performance status (Lansky or Karnofsky score ≥50).