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New treatment option for Recurrent Acute Lymphoblastic Leukemia
Official title Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
ClinicalTrials.gov ID: NCT05418088
What this study is testing
What is Anti-CD19/CD20/CD22 CAR T-Cells?
Anti-CD19/CD20/CD22 CAR T-Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent acute lymphoblastic leukemia.
Also referred to as Anti-CD19/20/22 Chimeric Antigen Receptor T-Cells, CD19/CD20/CD22-targeted CAR-T Cells.
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 phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL).
- 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 2 and older
You may be able to join if
- Adult people with relapsed or refractory non-Hodgkin lymphoma with lesions =\< 5 cm, indolent lymphomas, chronic lymphocytic leukemia without...
- OR adult people with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin...
- OR Pediatric people with Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- people must have been treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to...
- people with relapsed/refractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor...
You likely can't join if
- Autologous transplant within 6 weeks of planned CAR-T cell infusion
- Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off...
- Active graft versus host disease
- Active central nervous system or meningeal involvement by lymphoma or leukemia. people with untreated brain metastases/central nervous system (CNS)...
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast). Patients with a prior or concurrent...
- A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection
See the full eligibility criteria
Who can join
- Adult people with relapsed or refractory non-Hodgkin lymphoma with lesions =\< 5 cm, indolent lymphomas, chronic lymphocytic leukemia without Richter's transformation, or B-prolymphocytic leukemia (Cohort A)
- OR adult people with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions \> 5 cm and/or lymphoblastic lymphoma, or...
- OR Pediatric people with Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
- people must have been treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen. B-PLL is defined as...
- people with relapsed/refractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor and venetoclax
- people with refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant
- people with relapsed/refractory B-prolymphocytic leukemia who received at least 1- 2 prior lines of appropriate therapy and who have failed or are ineligible for allogeneic stem cell transplant
- people with relapsed/refractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy or who have failed or are ineligible for allogeneic stem cell transplant.
- The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and/or CD20 and/or CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral...
- Patients who received blinatumomab or inotuzumab are eligible.
- Patients who received prior CAR T-cells are eligible, (commercial CD 19 CAR-T cells or dual CAR-T cells), if it has been at least 30 days since previous CAR T cell therapy and \<5% of circulating levels of CD3+ cells...
- Age \>= 2 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 50
- Total bilirubin =\< 1.5 times the institutional upper limit of normal for age
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =\< 3 X institutional upper limit of normal for age
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 X institutional upper limit of normal for age
- Creatinine clearance more than or equal to 50 ml/min calculated by the Cockcroft - Gault formula, or by Schwartz formula for patients \< 18 years
- people must have adequate pulmonary function as defined as pulse oximetry \>= 92% on room air
- people must have adequate cardiac function as defined as left ventricular ejection fraction \>= 40% in the most recent echocardiogram
- Absolute lymphocyte count \> 100/uL
- people (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least...
- A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not...
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and...
- With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the human anti-CD19 CAR-T cell infusion to avoid potential embryonal or fetal...
What rules you out
- Autologous transplant within 6 weeks of planned CAR-T cell infusion
- Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents. Patients with live vaccines given 28 days prior to...
- Active graft versus host disease
- Active central nervous system or meningeal involvement by lymphoma or leukemia. people with untreated brain metastases/central nervous system (CNS) disease will be excluded from this clinical trial because of their poor...
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to...
- A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection
- Human immunodeficiency virus (HIV)-seropositive patients are allowable, however must be on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment to be eligible for this trial
- people with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or...
- Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative...
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy
- Patients with a positive hepatitis B core antibody or surface antigen are at high risk for hepatitis B virus (HBV) reaction and will require entecavir/tenofivir prophylaxis or serial hepatitis B (Hep B) PCR monitoring...
- Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease
- History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months
- Live vaccines given in 28 days prior to lymphodepleting chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.