Clinical trial
Use of Autologous Anti-CD22 CAR T Cells (CART22-65s) Co-administered With Humanized Anti-CD19 CAR T Cells (huCART19) in Children and Young Adults With Relapsed or Refractory B-ALL
Name
22-020640
Description
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).
Trial arms
Trial start
2023-01-25
Estimated PCD
2027-01-15
Trial end
2029-01-15
Status
Recruiting
Phase
Early phase I
Treatment
Autologous, humanized anti-CD22 CAR T cell therapy (CART22-65s)
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
Arms:
Dose Finding Arm, Expansion Arm
Other names:
CART22-65s
Autologous, humanized anti-CD19 CAR T cell therapy (huCART19)
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
Arms:
Dose Finding Arm, Expansion Arm
Other names:
huCART19
Size
93
Primary endpoint
Safety of CART22-65s and huCART19 co-administration
1 year
Efficacy of CART22-65s and huCART19 co-administration
1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 93, 'type': 'ESTIMATED'}}
Updated at
2023-12-19
1 organization
2 products
2 indications
Organization
Stephan GruppProduct
CART22-65sIndication
B-cell Acute Lymphoblastic LeukemiaIndication
B Lymphoblastic Lymphoma