BridgeMD
An adaptive open-label multicentre phase 1/2 trial, to determine the recommended phase 2 dose of CCTx-001, and to assess safety, tolerability, and clinical activity in patients with relapsed/refractory acute myeloid leukaemia (RESOLVE AML 001)
EU CTIS ID: 2023-506865-71-00
What this study is testing
Phase 1 - To evaluate the safety, tolerability, and to define the recommended RP2D of CCTx-001 Phase 2 - To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with active (> 5 % blasts in bone marrow) r/r AML defined as either: 1. Primary refractory: a. Patients who failed after two cycles of intensive induction including high-dose and/or standard dose cytarabine (including liposomal formulation), +/- anthracycline, +/- antimetabolite, +/- targeted therapy OR b. Older patients or patients unfit to receive intensive induction courses who failed after two cycles of venetoclax + azacitidine or 4 cycles of azacitidine 2. Relapsing: a. Patients with early relapse after CR to first line therapy (within ≤ 6 months after CR1) OR b. Patients with relapse after later lines of therapy (Relapse after CR≥2) 3. Patients relapsing after allogeneic hematopoietic stem cell transplant: a. Patients must be at least 3 months from HSCT at the time of consent, AND b. Off immunosuppression for at least 1 month at the time of consent, AND c. Have no active graft versus host disease (GvHD)
- Women of childbearing potential must have a negative serum pregnancy test
- Patients in reproductive age must be able and willing to use at least 1 highly effective method of contraception during the study and for 12 months after the last dose of LDC
- Have a circulating blast count of less than 20,000/mm3 (control with hydroxyurea is allowed)
- Absolute Lymphocyte count of >200/mm3
- Eastern Cooperative Oncology Group performance status ≤ 1
You likely can't join if
- Patients with acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia/retinoic acid receptor alpha) and variants
- Use of therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis, and within 72 hours prior to CCTx-001 infusion. Physiologic replacement, topical, and inhaled steroids are permitted
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment
- Active macrophage activation syndrome
- Active or prior history of hepatitis B or hepatitis C infection
- History of or active human immunodeficiency virus infection
See the full eligibility criteria
Who can join
- Patients with active (> 5 % blasts in bone marrow) r/r AML defined as either: 1. Primary refractory: a. Patients who failed after two cycles of intensive induction including high-dose and/or standard dose cytarabine (including liposomal formulation), +/- anthracycline, +/- antimetabolite, +/- targeted therapy OR b. Older patients or patients unfit to receive intensive induction courses who failed after two cycles of venetoclax + azacitidine or 4 cycles of azacitidine 2. Relapsing: a. Patients with early relapse after CR to first line therapy (within ≤ 6 months after CR1) OR b. Patients with relapse after later lines of therapy (Relapse after CR≥2) 3. Patients relapsing after allogeneic hematopoietic stem cell transplant: a. Patients must be at least 3 months from HSCT at the time of consent, AND b. Off immunosuppression for at least 1 month at the time of consent, AND c. Have no active graft versus host disease (GvHD)
- Women of childbearing potential must have a negative serum pregnancy test
- Patients in reproductive age must be able and willing to use at least 1 highly effective method of contraception during the study and for 12 months after the last dose of LDC
- Have a circulating blast count of less than 20,000/mm3 (control with hydroxyurea is allowed)
- Absolute Lymphocyte count of >200/mm3
- Eastern Cooperative Oncology Group performance status ≤ 1
- Life expectancy of more than 3 months
- Age ≥ 18 years at the time of informed consent
- Read, understood, and signed written informed consent form (ICF) prior to any study procedures
- Eligible for leukapheresis
- Adequate organ function
What rules you out
- Patients with acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia/retinoic acid receptor alpha) and variants
- Use of therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis, and within 72 hours prior to CCTx-001 infusion. Physiologic replacement, topical, and inhaled steroids are permitted
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment
- Active macrophage activation syndrome
- Active or prior history of hepatitis B or hepatitis C infection
- History of or active human immunodeficiency virus infection
- Known hypersensitivity or contraindication to DMSO, cyclophosphamide, fludarabine, or their excipients
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol
- History of any of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
- Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting LDC
- Patients with active central nervous system (CNS) leukaemia involvement or isolated extramedullary AML disease
- Patients who underwent allo-HSCT within 90 days prior to leukapheresis
- Patients with active GvHD
- Patients who received previous treatment targeting IL-1RAP or previous gene therapy
- Patients with history of another primary malignancy other than disease under study unless the patient has been free of the disease for ≥ 2 years, except for the following non-invasive malignancies: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative, or other completely resected stage 1 solid tumour with low risk of recurrence
- Patients with history or presence of an active and clinically relevant CNS disorder
- Patients with active autoimmune disorders or active neurological or inflammatory disorders (e.g., Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis)
- Use of immunosuppressive therapies within 4 weeks prior to signing the ICF (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-tumour necrosis factor, anti-interleukin 6, or anti-interleukin 6 receptor)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.