Phase 1 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with one of the following blood cancers: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), chronic myeloid leukemia (CML), T-cell acute lymphoblastic leukemia/lymphoma (T-ALL), or multiple myeloma, diagnosed according to recognised international criteria.
• People whose cancer has a specific mutation in the TP53 or RAS gene (from a list of targeted mutations), detected at a level of at least 5% in a bone marrow sample tested in the NCI Laboratory of Pathology within 60 days before the cell collection procedure (apheresis).
• People who have a specific immune system tissue type (HLA type) that matches one of the targeted mutations listed in the trial — for example, HLA type A*02:01 paired with a TP53 R175H mutation (confirm with trial site for the full matching table).
• People with AML or MDS whose bone marrow contains at least 5% blast cells (abnormal cancer cells), confirmed by laboratory testing.
• People with T-ALL whose bone marrow contains at least 5% T-cell blast cells.
• People with multiple myeloma whose bone marrow shows abnormal plasma cells detected by specialised testing, or at least 6% total plasma cells on biopsy.
• People with CMML whose bone marrow contains at least 6% blast cells.
• People with CML whose blood or bone marrow shows a measurable level of the BCR-ABL1 cancer marker above a defined threshold on an internationally standardised scale.
• People with AML, MDS, CML, CMML, or T-ALL who have not had a stem cell transplant from a donor (alloHSCT) and who are either unable or unwilling to have one.
• People with AML whose cancer did not go into remission after initial treatment, regardless of transplant history.
• People with MDS who have been assessed as high or very high risk using standard scoring tools, and who have previously received at least one of the following: a hypomethylating agent, chemotherapy, or a donor stem cell transplant.
• People with MDS/AML who have a TP53 mutation.
• People with CMML who have been scored as intermediate-2 or high risk using a recognised scoring system, and who have received at least one prior systemic treatment.
• People with CML in the chronic phase who have tried three or more targeted therapy drugs (tyrosine kinase inhibitors, or TKIs) without adequate response or due to side effects, or who have received specific combinations of these drugs; people with CML in accelerated phase or blast crisis who have received at least one TKI.
• People with T-ALL whose cancer did not go into complete remission after initial treatment, or whose cancer has come back.
• People with relapsed AML who are unable to have a donor stem cell transplant and meet other criteria.
• People with multiple myeloma who have received at least three prior treatment regimens, including specific drug types (an IMiD such as lenalidomide, a proteasome inhibitor, and a BCMA-targeting therapy), and whose myeloma is measurable by at least one of: a serum M-protein level of 1.0 g/dL or more, urine M-protein of 200 mg or more over 24 hours, a free light chain level meeting specific criteria, a biopsy-confirmed tumour deposit of at least 2 cm, or bone marrow plasma cells of 30% or more.
• People aged 18 to 75 years old.
• People who are in good general health, rated as ECOG performance status 0 or 1 (meaning fully active or able to carry out light activity).
• People whose blood counts and organ function meet specific minimum levels, including haemoglobin, platelets, neutrophils, liver enzymes, bilirubin, and kidney function (confirm specific thresholds with trial site).
• People whose heart pumping function is 50% or greater on an echocardiogram (heart ultrasound) done within 30 days before apheresis, with no significant fluid around the heart.
• People who have less than or equal to 1% blast or plasma cells in their blood count before apheresis.
• People who have not received systemic chemotherapy for at least 14 days before the start of the trial's chemotherapy or apheresis, and whose chemotherapy-related side effects (other than low blood counts) have largely resolved.
• People who previously received a donor stem cell transplant from a fully matched sibling or a 10 out of 10 HLA-matched unrelated donor, and who are at least 100 days past that transplant.
• People who previously had donor stem cell transplants and have no active acute graft-versus-host disease (GVHD), and no chronic GVHD or only mild chronic GVHD (confirm definition with trial site).
• People who have previously received engineered T-cell therapies, provided at least 180 days have passed since that T-cell treatment and the apheresis procedure.
• People whose blood oxygen level on room air is 93% or higher.
• People with a significant smoking history, lung disease, prior donor stem cell transplant, or ongoing lung symptoms who have lung function test results meeting specific minimum thresholds.
• People who test negative for hepatitis B surface antigen and hepatitis B core antibody, or who test negative on a blood PCR test for hepatitis B if either of those tests is positive.
• People who test negative for hepatitis C antibody, or who test negative on a blood PCR RNA test for hepatitis C if that antibody test is positive.
• People who are willing to undergo intensive care if needed, including mechanical ventilation.
• People who are willing to have bone marrow biopsies during the study.
• People who are willing to stay within a one-hour drive of the NIH Clinical Center from the time of first discharge until at least 14 days after the T-cell infusion.
• People who are willing to be enrolled in two additional NCI study protocols (03C0277 and 09C0161).
• Women who could become pregnant must agree to use highly effective contraception from study entry through 12 months after the last chemotherapy dose.
• Men who could father children must agree to use effective contraception during treatment and for 4 months after the last chemotherapy dose, and must not freeze or donate sperm during this period.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment through 4 months after the last study drug dose.
• People who are able to understand the study and are willing to sign a written informed consent document and a durable power of attorney.

Who may not be able to join:

• People who have received immune-suppressing medications, including corticosteroids at doses above 5 mg per day of prednisone or equivalent, within 28 days before apheresis (this applies to people who have had a prior donor stem cell transplant); note that skin creams, inhaled steroids, and eye drops are generally allowed.
• People who have received corticosteroids at doses above 5 mg per day of prednisone or equivalent for any reason within 14 days before apheresis or the start of the trial's chemotherapy.
• People diagnosed with MDS/myeloproliferative neoplasm overlap syndromes.
• People diagnosed with acute promyelocytic leukemia.
• People who received a mismatched sibling or half-matched (haploidentical) donor stem cell transplant.
• People with a tumour mass measuring 10 cm or more at its largest point.
• People who are pregnant, as shown by a positive pregnancy test.
• People who test positive for HTLV-1 or HTLV-2 (a type of viral infection).
• People who are HIV positive.
• People who need urgent treatment due to the cancer pressing on a vital organ or causing tumour lysis syndrome.
• People with a significant illness that, in the opinion of the principal investigator, may make it unsafe to participate in the study.
• People with a history of another cancer that has not been in complete remission for at least 2 years, or that required surgery, radiation, or chemotherapy (including ongoing hormonal therapy) within the past 2 years — exceptions may apply for certain treated skin cancers (confirm with trial site).
• People with an active uncontrolled infection, including unexplained fever above 38°C in the past 24 hours, or people currently on intravenous antibiotics that have been given for less than 72 hours.
• People who have the diagnosis of atypical CML (this is specifically excluded from the eligible diagnoses).

Important: Always verify eligibility with the trial site directly before applying.