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New treatment option for Hematological Malignancy
Official title Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances
ClinicalTrials.gov ID: NCT05110742
What this study is testing
What is Fludarabine Phosphate?
Fludarabine Phosphate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematological malignancy.
Also referred to as Fludarabine, Fludara®.
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
- To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow...
- Patients must meet diseases specific eligibility criteria (see below)
- Patients should be at least 1 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue...
- Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not...
- Karnofsky Performance Scale \> 50%.
You likely can't join if
- Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating...
- Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
- Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
- Active hepatitis B or C.
- HIV with detectable viral load.
- Presence of active neurological disorder(s).
See the full eligibility criteria
- Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry.
- Patients must meet diseases specific eligibility criteria (see below)
- Patients should be at least 1 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least...
- Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.
- Karnofsky Performance Scale \> 50%.
- Adequate organ function:
- Renal: Serum creatinine ≤ 2.0ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml/min/1.73 m2.
- Hepatic: ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0ULN, except in people with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver...
- Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease.
- Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \> 92% on room air.
- Able to provide written informed consent.
- 18-80 years of age.
- Weight ≥40 kg.
- English and non-English speaking patients are eligible.
- All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include...
- Signed consent to long-term follow-up protocol PA17-0483.
- Disease specific A. T-cell non-Hodgkin's lymphoma and T-cell acute lymphoblastic leukemia
- Patients with history of T-lymphoid malignancies, defined as acute lymphoblastic leukemia (ALL/T-LBL), Peripheral T-cell lymphoma (PTCL-NOS), MF/SS, Hepatosplenic gamma/delta NHL, AITL, ALCL, or other subtypes of T cell...
- Patients with history of T-lymphoid malignancies as defined above with relapsed disease following standard therapy or a stem cell transplant. B. Chronic lymphocytic leukemia (CLL) Chronic lymphocytic leukemia (CLL)...
- Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
- Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
- Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
- Active hepatitis B or C.
- HIV with detectable viral load.
- Presence of active neurological disorder(s).
- Active autoimmune disease within 12 months of enrollment
- Active cerebral or meningeal involvement by the malignancy
- Active (defined as requiring therapy) acute or chronic GVHD.
- Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
- Presence of any other serious medical condition that may endanger the patient at investigator criteria.
- Major surgery \<4 weeks prior to first dose of study drug
- Allogeneic SCT or DLI \<12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior enrollment in the study.
- Concomitant use of other investigational agents.
- Concomitant use of other anti-cancer agents.
- Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of...
- Patients receiving immunosuppressive therapy.
- Patients with diminished mental capacity will not be enrolled on the study.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.