Leukemia, Myeloid, Acute study: Treatment Arm A
Official title Chimeric Antigen Receptor Treatment Targeting CD70 (SEVENTY)
ClinicalTrials.gov ID: NCT06345027
What this study is testing
What is Treatment Arm A?
Treatment Arm A is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for leukemia, myeloid, acute.
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 study is for patients who have a type of blood cancer that expresses the protein CD70, which includes acute myeloid leukemia (AML), T-cell leukemia or B-cell leukemia (and the leukemia has come back or has not gone away after standard of care treatment). As there are limited or no remaining standard treatments available to treat this cancer, subjects are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the leukemia cells in a subject's body.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 75
You may be able to join if
- Procurement
- Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL).
- CD70 positive leukemia with at least 26% CD70+ blasts by flow cytometry or immunohistochemistry (staining can be pending at time of procurement)
- Age ≤75 years. NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
You likely can't join if
- Diagnosis of acute promyelocytic leukemia (APL)
- Active infection (bacterial, fungal, or viral) requiring ongoing treatment without improvement.
- Known active infection with HIV or HTLV (collected blood will be sent for HIV/HTLV testing, separate testing prior to procurement not required).
- Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to...
- Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) Patients with...
- Confirmation from the patient's primary physician team of a suitable allogeneic hematopoietic stem cell transplant (HSCT) donor.
See the full eligibility criteria
- Procurement
- Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL).
- CD70 positive leukemia with at least 26% CD70+ blasts by flow cytometry or immunohistochemistry (staining can be pending at time of procurement)
- Age ≤75 years. NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- If apheresis required to collect blood
- PT and aPTT \<1.5x ULN
- Serum Creatinine \< 2 x ULN
- AST \< 5 x ULN
- Informed consent Procurement
- Diagnosis of acute promyelocytic leukemia (APL)
- Active infection (bacterial, fungal, or viral) requiring ongoing treatment without improvement.
- Known active infection with HIV or HTLV (collected blood will be sent for HIV/HTLV testing, separate testing prior to procurement not required).
- Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment
- Diagnosis of primary refractory or relapsed Acute Myeloid Leukemia (AML) with the exception of acute promyelocytic leukemia (APL) Patients with targetable mutations should have failed or be ineligible for targeted...
- Confirmation from the patient's primary physician team of a suitable allogeneic hematopoietic stem cell transplant (HSCT) donor. OR Documentation that patient declines a potential subsequent HSCT)
- CD70 positive leukemia with at least 26% CD70+ cells by flow cytometry or immunohistochemistry (tissue)
- No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment.
- Age ≤ 75 years. NOTE: The first three (3) patients treated on the study should be adults (≥18 years of age).
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- Total bilirubin \< 3 times the upper limit of normal
- AST/ALT \< 5 times the upper limit of normal
- Estimated GFR ≥ 60ml/min
- Pulse oximetry of \> 90% on room air
- Karnofsky/Lansky score of ≥ 60%
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. Male partner should use a condom
- Diagnosis of acute promyelocytic leukemia (APL)
- Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks.
- Pregnant or lactating.
- Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is \>350 mm3.
- Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.
- Cardiac abnormalities: Cardiac echocardiography with LVEF\<50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions within 6 months of treatment.
- Presence of CNS disease: Defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 or known CNS tumors/chloromas (repeat spinal tap within 4 weeks only required for leukemia patients with...
- Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days
- Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days
- Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD
- High dose steroids \>1 mg/kg within preceding 5 days or currently receiving \>0.5mg/kg/day prednisone equivalent
- Hyperleukocytosis (WBC ≥ 50K) or rapidly progressive disease that in the estimation of the investigator would compromise the ability of the patient to complete the initial 6 weeks of the study
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
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, but 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, up to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.