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Trial Title:
Co-administration of CART22-65s and huCART19 for B-ALL
NCT ID:
NCT05674175
Condition:
B-cell Acute Lymphoblastic Leukemia
B Lineage Lymphoblastic Lymphoma
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)
Description:
CART22-65s are autologous T cells that have been engineered to express an extracellular
single chain antibody (scFv) with specificity for CD22 linked to an intracellular
signaling molecule consisting of a tandem signaling domain comprised of the TCRζ
signaling module linked to the 4-1BB costimulatory domain
Arm group label:
Dose Finding Arm
Arm group label:
Expansion Arm
Other name:
CART22-65s
Intervention type:
Biological
Intervention name:
Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)
Description:
HuCART19 cells are autologous T cells that have been engineered to express an
extracellular single chain antibody (scFv) with specificity for CD19 linked to an
intracellular signaling molecule consisting of a tandem signaling domain comprised of the
TCRζ signaling module linked to the 4-1BB costimulatory domain
Arm group label:
Dose Finding Arm
Arm group label:
Expansion Arm
Other name:
huCART19
Summary:
This study will evaluate the safety and efficacy of administering two CAR T cell
products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic
Leukemia (B-ALL).
Detailed description:
CD19-targeted CAR T cell therapy has transformed the treatment landscape for children and
young adults with chemo-refractory or relapsed B cell Acute Lymphoblastic Leukemia
(B-ALL). Despite remarkable initial response rates, approximately 50% of pediatric
patients experience a subsequent disease relapse. The prognosis for these patients is
dismal with a median survival of less than one year from the time of post-CART19 relapse.
The primary mechanisms contributing to CART19 failure include CD19-antigen escape and
loss of CAR T cell surveillance due to short CART persistence. This study aims to counter
each driver of relapse by co-administering two next-generation CAR T cell products: an
anti-CD22 CART (CART22-65s), designed to overcome CD19-antigen escape; and a humanized
anti-CD19 CART (huCART19), designed to overcome immune-mediated rejection of murine
CART19.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent form
2. Patients with documented CD19+ and/or CD22+ ALL/LLy:
1. Cohort A: Patients with relapsed or refractory ALL/LLy:
2. Cohort B: Patients with poor response to prior B cell directed engineered cell
therapy
3. Patients with prior or current history of Central Nervous System 3 disease will be
eligible if Central Nervous System disease is responsive to therapy
4. Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood,
Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last
detectable disease. If the patient has experienced a relapse after CD19-directed
and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy
to demonstrate CD19 and/or CD22 expression.
5. Age 0-29 years
6. Adequate organ function
7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.
8. Subjects of reproductive potential must agree to use acceptable birth control
methods.
Exclusion Criteria:
1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy
4. Concurrent use of systemic steroids or immunosuppression 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 or immunosuppression 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.
5. Central nervous system disease that is progressive on therapy, or with Central
nervous system parenchymal lesions that might increase the risk of central nervous
system toxicity.
6. Pregnant or nursing (lactating) women
7. Uncontrolled active infection
Gender:
All
Minimum age:
N/A
Maximum age:
29 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Varghese
Phone:
845-553-5358
Email:
Varghesem@chop.edu
Start date:
January 25, 2023
Completion date:
January 15, 2029
Lead sponsor:
Agency:
Stephan Grupp MD PhD
Agency class:
Other
Collaborator:
Agency:
University of Pennsylvania
Agency class:
Other
Source:
Children's Hospital of Philadelphia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674175