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New treatment option for Relapsed Refractory Acute Lymphoblastic Leukemia
Official title CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07361029
What this study is testing
- What it's testing
- This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
- 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 18 to 75
You may be able to join if
- Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed informed consent form 3. Ability to...
- Second or greater bone marrow (BM) relapse; or
- Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined...
- Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
- Relapsed patients ineligible for Allogeneic Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
You likely can't join if
- Clinically Active central nervous system (CNS) involvement by malignancy
- History or presence of uncontrolled underlying seizure disorder not related to B-ALL
- History of or active clinically significant cardiovascular dysfunction, including any of the following:
- History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
- History of transient ischemic attack within 12 months prior to the CD19 CAR T cells infusion
- History of myocardial infarction within 36 months prior to the CD19 CAR T cells infusion
See the full eligibility criteria
Who can join
- Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed informed consent form 3. Ability to comply with the study protocol 4. Relapsed/refractory B-cell acute...
- Second or greater bone marrow (BM) relapse; or
- Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for...
- Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
- Relapsed patients ineligible for Allogeneic Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
- Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant immunosuppression
- Relapsed after prior CAR T cell and still CD19 positive. . (Patients with a history of ≥grade CRS, ≥ grade 3 ICANS, or severe hypersensitivity reactions following prior CAR T-cell therapy should be excluded.) 5. BM with...
- Renal Function: Glomerular Filtration Rate (GFR) \> 60mL/min.
- Hepatic Function: AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome).
- Pulmonary Function: Adequate respiratory function defined as oxygen saturation ≥ 93% on room air.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA scan and QTcF ≤ 480 ms. 15. Minimum level of pulmonary reserve defined as grade ≤1 dyspnea and pulse oxygenation \>93% on room...
- Females should use effective birth control 1 month prior to screening until 12 months after CAR T cell infusion
- Males to use condom for six months after infusion 20. Meet institutional criteria to undergo leukapheresis or have an acceptable, stored leukapheresis product
What rules you out
- Clinically Active central nervous system (CNS) involvement by malignancy
- History or presence of uncontrolled underlying seizure disorder not related to B-ALL
- History of or active clinically significant cardiovascular dysfunction, including any of the following:
- History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
- History of transient ischemic attack within 12 months prior to the CD19 CAR T cells infusion
- History of myocardial infarction within 36 months prior to the CD19 CAR T cells infusion
- Symptomatic congestive heart failure (NYHA class III/IV), unstable angina pectoris, cardiac arrhythmia requiring therapy
- Uncontrolled arrhythmias, or history of or active ventricular arrhythmia requiring medication
- Active or history of coronary heart disease that remains symptomatic
- Active or history of unstable or stable angina
- Left ventricular ejection fraction (LVEF) \< 45% confirmed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) scan
- Creatinine clearance \< 60
- Concomitant genetic syndromes associated with Bone Marrow (BM) failure states, such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome; patients with Down syndrome are not...
- Burkitt lymphoma/leukemia
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
- Treatment with any prior gene therapy product (except prior CAR-T cell therapy)
- Positive HIV test within 8 weeks of screening
- Serologic status reflecting active hepatitis B or C infection: Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain...
- Received an investigational medicinal product on trial within the 30 days prior to screening
- Pregnant
- Lactating
- Women of child-bearing potential and all male participants, unless using highly effective methods of contraception for 1 year after CAR-T infusion
- Therapeutic systemic doses of steroids (\>=0.5mg/kg prednisone equivalent) must be stopped \>72 hours prior to lymphodepletion
- TKIs and hydroxyurea must be stopped \>72 hours prior to lymphodepletion
- The following drugs must be stopped \>1 week prior to lymphodepleting chemotherapy: vincristine, 6- mercaptopurine, 6-thioguanine, methotrexate 2 weeks prior to CART infusion: salvage chemotherapy (e.g., clofarabine...
- Pegylated asparaginase must be stopped \>4 weeks prior to CAR T cell infusion
- CNS disease prophylaxis and/or intrathecal chemotherapy must be stopped \>1 week prior to CAR T cell infusion
- Radiation therapy at non-CNS site must be completed \>2 weeks prior to CAR T Cell infusion
- CNS-directed radiation must be completed \>8 weeks prior to CAR T cell infusion
- Known History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (including, but not limited to, cyclophosphamide and fludarabine used in the...
- Autologous transplant within 6 weeks of planned CAR-T cell infusion
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Primary Immunodeficiency Patients:
- Patients with known primary immunodeficiency disorders are excluded due to increased risk of adverse outcomes.
- Recent Live Vaccine Administration:
- Patients who have received a live vaccine within 4 weeks prior to enrolment are excluded.
- Additionally, vaccination with live vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Riyadh, Riyadh Region, Saudi Arabia
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Riyadh, Riyadh Region, Saudi Arabia. Enter your location above to see the nearest site and check your eligibility.
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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.