Status:
TERMINATED
Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma
Lead Sponsor:
AGC Biologics S.p.A.
Collaborating Sponsors:
Horizon 2020 - European Commission
Conditions:
Acute Myeloid Leukemia
Multiple Myeloma
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this first-in-man Phase I-IIa study is to evaluate the safety and antitumor activity of autologous CD44v6 CAR T-cells in patients with acute myeloid leukemia (AML) and multiple myeloma ...
Detailed Description
The study is a seamless Phase I/IIa, open-label, multicenter clinical trial that combines Phase I dose escalation based on toxicity with Phase IIa dose expansion based on antitumor activity. Consideri...
Eligibility Criteria
Inclusion
- Patients must meet all the following inclusion criteria to be eligible for the study.
- Written informed consent before any study-related procedure.
- Adults and children:
- Adults 18 to 75 (65) years old with AML or MM.
- Children 1 to 17 years old with AML, only in Phase IIa.
- Confirmed diagnosis of AML or MM as follows:
- AML: Primary or secondary AML (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) classification.
- MM with measurable disease as defined by the International Myeloma Working Group (IMWG).
- Patients with relapse or refractory disease:
- AML patients must be unlikely to benefit from cytotoxic chemotherapy as follows:
- Leukemia refractory to at least 2 induction attempts.
- Leukemia in relapse within 1 year following complete response (CR) after at least 2 induction attempts.
- High-risk leukemia in adults according to 2017 European LeukemiaNet (ELN) in first relapse after a hypomethylating agent or a cycle containing cytarabine at a dose ≥ 1g/sqm a day (e.g. FLAG-IDA), except for FLT3-mutated AML.
- High-risk leukemia in children as defined by the Italian Association of Pediatric Hematology and Oncology (AIEOP).
- Patients with MM must have a relapse or refractory disease after at least 4 different prior treatments in 3 treatment lines, or 4 treatments in 2 treatment lines in case of early relapsing patients (relapse in less than 1.5 years). Treatments include:
- Proteasome inhibitor
- High-dose alkylating agent if patients less than 70 years old
- Immunomodulatory drug (IMID)
- A monoclonal antibody (i.e. anti CD38 monoclonal antibody)
- Positive CD44v6 expression on tumor cells by flow cytometry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Life expectancy of at least 12 weeks.
- Adequate organ function (hepatic, cardiac, pulmonary).
- Recovery from toxicities of clinical consequence attributed to previous chemotherapy to CTCAE v5.0 Grade 1 (i.e., certain toxicities such as alopecia will not be considered in this category).
- Ability to comply with study procedures, including hospitalization and protocol-specified acquisition of blood and/or bone marrow specimens.
- Willing to be followed up long term, i.e. a 15-year follow up as required by health authorities for cell and gene therapy products.
- Women of childbearing potential must test negative for pregnancy at enrolment and during the study.
Exclusion
- At screening: patients must meet none of the following exclusion criteria to be eligible for the study:
- History of or candidate for allogeneic stem cell transplantation.
- Cardiovascular, pulmonary, renal, and hepatic functions that in the judgment of the investigator are insufficient for the patient to undergo investigational CAR T-cell therapy.
- Any history of or suspected current autoimmune disorders (apart from vitiligo, resolved childhood atopic dermatitis, Graves' disease clinically controlled).
- History of rheumatologic disorders requiring specific treatment at any time in the patient's medical history.
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04097301
Start Date
August 27 2019
End Date
June 18 2021
Last Update
January 19 2022
Active Locations (3)
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1
Department of Haematooncology, Fakultni Nemocnice
Ostrava, Czech Republic, Czechia
2
IRCCS San Raffaele
Milan, Italy
3
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Italy