Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR) for Leukemia, Lymphocytic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, LymphocyticAllogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR) - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if it is safe to use donor-derived CAR T cells to treat adults with B-cell ALL.

Eligible Conditions
  • Leukemia, Lymphocytic

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 1 year

1 year
Cumulative incidence of disease progression
Frequency of secondary graft failure
Infectious disease complication
Overall survival
Progression-free survival
42 days
Bone Transplantation
Number of patients who received donor CD19/CD22-CAR T cells

Trial Safety

Trial Design

2 Treatment Groups

Cell Infusions CD34+ HSPC Treg (Orca-T)
1 of 2
Dose escalation
1 of 2

Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR) · No Placebo Group · Phase 1

Cell Infusions CD34+ HSPC Treg (Orca-T)Experimental Group · 2 Interventions: Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR), Treg CD34+ HSPC (Orca-T) · Intervention Types: Drug, Drug
Dose escalationExperimental Group · 2 Interventions: Treg CD34+HSPC (Orca-T), Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR) · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
203 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,170 Previous Clinical Trials
35,768,265 Total Patients Enrolled
2 Trials studying Leukemia, Lymphocytic
57 Patients Enrolled for Leukemia, Lymphocytic
Orca Biosystems, Inc.Industry Sponsor
5 Previous Clinical Trials
606 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD in the peripheral blood or bone marrow on two occasions at least 2 weeks apart.
You are 18 years of age or older.\n
Subjects must have an HLA matched related donor willing to undergo unstimulated apheresis for T cell collection for CAR T cell generation followed by GCSF mobilized apheresis for HSC/Treg graft.
You have a cardiac ejection fraction at rest of ≥ 45%.
Subjects with active ALL are eligible.
You have a total bilirubin level of less than 2 times the upper limit of normal (ULN).