Description:
This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19
cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This
study is targeting pediatric and young adult patients aged 1-29 years with CD19+ B cell
malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome
with conventional chemotherapy, in high-risk first relapse, or and in second or greater
relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of
huCART19 in patients with poor response to prior B cell directed engineered cell therapy.
Title
- Brief Title: Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
- Official Title: Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)
Clinical Trial IDs
- ORG STUDY ID:
831916
- SECONDARY ID:
18CT014
- NCT ID:
NCT03792633
Conditions
Interventions
Drug | Synonyms | Arms |
---|
huCART19 | huCTL019 | Newly Diagnosed VHR B-ALL or High-Risk Relapse of B |
Purpose
This is a phase 2 study to evaluate humanized CD19 redirected autologous T cells (or huCART19
cells) with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia. This
study is targeting pediatric and young adult patients aged 1-29 years with CD19+ B cell
malignancies in newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome
with conventional chemotherapy, in high-risk first relapse, or and in second or greater
relapse in this phase 2 trial. In addition, a second cohort will test the efficacy of
huCART19 in patients with poor response to prior B cell directed engineered cell therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Newly Diagnosed VHR B-ALL or High-Risk Relapse of B | Experimental | | |
Poor Response to Prior B Cell Directed Engineered cell therapy | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory B-cell ALL:
- Cohort A: Patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL who
meet one of the following criteria:
- Newly diagnosed NCI HR B-ALL with induction failure: M3 marrow (>25% blasts) at
end of induction OR
- First marrow relapse of B-ALL at < 36 months from diagnosis OR
- 2nd or greater relapse OR
- Any relapse after allogeneic hematopoietic stem cell transplantation (HSCT) and ≥
4 months from stem cell transplant (SCT) at enrollment OR
- Refractory disease defined as having not achieved a minimal residual disease
(MRD)_-negative and/or cerebral spinal fluid (CSF)-negative complete response
(CR) after ≥ 2 chemotherapy regimens/cycles of frontline therapy or 1 cycle of
reinduction therapy for patients in first relapse OR
- Ineligible for allogeneic stem cell transplant
- Cohort B: Patients previously treated with B cell directed engineered cell therapy who
meet one of the following criteria:
- partial response or no response to prior cell therapy
- CD19+ relapse after prior cell therapy
- demonstrated early (≤6 months from infusion) B cell recovery suggesting loss of
engineered cells
- Patients with prior or current history of CNS3 disease will be eligible if central
nervous system (CNS) disease is responsive to therapy
- Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor
tissue by flow cytometry at relapse
- Adequate organ function
- Age 1-29 years
- Adequate performance status
Exclusion Criteria:
- 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.
Maximum Eligible Age: | 29 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 1-year Event-Free Survival in patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Pennsylvania |
Last Updated
June 24, 2021