CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

Running, not enrolling · Phase 1

Conditions studied: B Acute Lymphoblastic Leukemia

In brief

This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of B-cell acute lymphoblastic leukemia.

Key facts

Study ID: NCT05707273
Run by: City of Hope Medical Center
People needed: 18
Starts: 2023-04-26
Expected to finish: 2026-07-24
Last updated by the study team: 2026-04-24

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented informed consent of the participant
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with Study Principal Investigator (PI) approval
Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Age: >= 55 years
Eastern Cooperative Oncology Group (ECOG) < 2 / Karnofsky Performance Status (KPS) >= 70
Ability to read and understand English for Questionnaires
Histologically confirmed CD19+ ALL at the time of diagnosis
In morphological first complete remission regardless of minimal residual disease (MRD) status
No immediate plan for transplant
Remission after induction +/- reinduction therapy
Fully recovered from the acute toxic effects (except alopecia) to =< Grade 1 to prior anti-cancer therapy
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
Aspartate aminotransferase (AST) =< 3 x ULN
Alanine transaminase (ALT) =< 3 x ULN
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Left ventricular ejection fraction (LVEF) >= 50%
Note: To be performed within 28 days prior to start of protocol therapy
Oxygen (O2) saturation > 92% on room air.
Note: To be performed within 28 days prior to start of protocol therapy
Seronegative for human immunodeficiency virus (HIV) (quantitative polymerase chain reaction [qPCR]), hepatitis C virus (HCV), active hepatitis B virus (HBV) (Surface Antigen Negative), and syphilis (rapid plasma reagin [RPR])
If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR
If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
Meets other institutional and federal requirements for infectious disease titer requirements
Note Infectious disease testing to be performed within 28 days prior to start of protocol therapy

You may not qualify if…

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent(s)
Research participant with known CNS-2 or CNS-3 involvement that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation. Research participants with a history of central nervous system (CNS) disease that has been effectively treated to complete remission (<5 WBC/mm3 and no blasts in cerebrospinal fluid [CSF]) will be eligible
Autoimmune disease or active graft versus host disease (GVHD) requiring systemic immunosuppressant therapy
Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification
History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for >= 2 years
Clinically significant uncontrolled illness
Active systemic uncontrolled infection requiring antibiotics
Known history of HIV or hepatitis B or hepatitis C infection
Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded
Subjects who are hepatitis B core antibody positive (or have a known history of HBV infection) should be monitored quarterly with a quantitative PCR test for HBV deoxyribonucleic acid (DNA). HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core Ab positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment
Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded
Females only: Pregnant or breastfeeding
Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =< 7.5 mg /day or equivalent) is allowed
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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