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New treatment option for Acute Myeloid Leukemia (AML)
Official title Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07668557
What this study is testing
What is Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide?
Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Written informed consent approved by IRB/IEC obtained from subject or legally authorized representative prior to any screening procedures.
- Age ≥ 18 years and ≤ 70 years at the time of informed consent signing.
- Diagnosis of acute myeloid leukemia (AML) per 2022 WHO Classification, meeting criteria for relapsed/refractory (R/R) AML as defined in the Chinese...
- Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry.
- If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry.
You likely can't join if
- Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.
- Severe major organ dysfunction: Renal: eGFR \ 3 × ULN (\>5×ULN if disease-related), total bilirubin \> 2 × ULN (\>3×ULN for Gilbert syndrome)...
- Active uncontrolled infection: positive HBsAg/HBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV...
- Unstable severe systemic disease requiring continuous medication.
- Grade \>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.
- Uncontrolled life-threatening bacterial, fungal or viral infection.
See the full eligibility criteria
- Written informed consent approved by IRB/IEC obtained from subject or legally authorized representative prior to any screening procedures.
- Age ≥ 18 years and ≤ 70 years at the time of informed consent signing.
- Diagnosis of acute myeloid leukemia (AML) per 2022 WHO Classification, meeting criteria for relapsed/refractory (R/R) AML as defined in the Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory...
- Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry.
- If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry.
- ECOG performance status 0-2.
- Expected overall survival \> 3 months.
- Females of childbearing potential: negative serum pregnancy test and effective contraception for 1 year post-infusion. Males of reproductive potential: effective barrier contraception for 1 year post-infusion and no...
- Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.
- Severe major organ dysfunction: Renal: eGFR \ 3 × ULN (\>5×ULN if disease-related), total bilirubin \> 2 × ULN (\>3×ULN for Gilbert syndrome); Cardiac: LVEF \< 50%, room air SpO₂ \<94%, uncontrolled severe cardiac...
- Active uncontrolled infection: positive HBsAg/HBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV or CMV viremia.
- Unstable severe systemic disease requiring continuous medication.
- Grade \>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.
- Uncontrolled life-threatening bacterial, fungal or viral infection.
- Non-leukemic central nervous system organic disease or active CNS-2/CNS-3 leukemia; previously treated and resolved CNS leukemia is permitted.
- Concurrent other malignant tumor except cured in-situ carcinoma or malignancies with ≥5 years continuous complete remission.
- Live-attenuated vaccines within 30 days before screening or planned within 3 months after CAR-T infusion.
- Received any other investigational medicinal product within 3 months prior to ICF signature.
- Allogeneic hematopoietic stem cell transplantation within 6 months before screening.
- Pregnant or breastfeeding women.
- Suicidal tendency, ongoing alcohol or illicit drug dependence.
- Known hypersensitivity to investigational product, excipients or concomitant drugs.
- Any other condition judged inappropriate for trial entry by investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. 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 ClinicalTrials.gov; the study team decides eligibility.