A Phase II Study to Evaluate the Efficacy of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

Starting soon · Phase 2

Conditions studied: Lymphoma Nonhodgkin, Marginal Zone B Cell Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Follicular B-cell Non-Hodgkin's Lymphoma, CAR T Cell Therapy

In brief

The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured t…The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured through an ultra-fast (less than 1 day) process, can treat adult patients (18 years and older, male or female) with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL), including Large B-Cell Lymphoma (LBCL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL). The participants will be divided in two cohorts: 81 participants in Cohort 1: Large B-Cell Lymphoma (LBCL) 24 participants in Cohort 2: Follicular Lymphoma (FC) and Marginal Zone Lymphoma (MZL) The main questions it aims to answer are: 1. Can UF-KURE19 achieve a clinically meaningful complete response rate (CRR) of ≥ 45% in patients with relapsed/refractory LBCL at Day 90 post-infusion, per Lugano Revised Response Criteria? 2. Can UF-KURE19 achieve a CRR of ≥ 60% in patients with relapsed/refractory Follicular or Marginal Zone Lymphoma at Day 90 post-infusion? There is no comparison group. This is a single-arm study, (all participants receive UF-KURE19) with 2 cohorts as outlined above. Participants will: 1. Undergo leukapheresis for collection of their own T cells, which will be used to manufacture UF-KURE19. 2. Subsequently they will receive a single intravenous infusion of UF-KURE19 (10×10⁶ cells for patients ≥50kg; 7×10⁶ cells for patients \<50kg) Complete disease response assessments at Day 90 post-infusion per Lugano criteria 3. Undergo safety monitoring including adverse event collection, laboratory tests, neurological exams, CAR-T persistence assays, and replication-competent lentivirus (RCL) testing throughout the study 4. Be followed long-term for up to 15 years post-infusion for gene therapy safety surveillance per FDA requirements

Key facts

Study ID: NCT07713459
Run by: Kure Cells, INC
People needed: 105
Starts: 2026-08-31
Expected to finish: 2029-11-30
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female patients aged 18 years or older.
Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.
Subjects in cohort 1 (LBCL) must meet the following inclusion criteria:
a. Subjects must fit one of the following diagnoses: i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) ii. High-grade B-cell lymphoma iii. Primary mediastinal large B-cell lymphoma iv. Follicular lymphoma grade 3B b. LBCL disease status must consist of one of the following: i. Relapsed after 2 or more lines of chemoimmunotherapy OR ii. Disease that is refractory to first line chemoimmunotherapy or relapses within 12 months of completion of initial chemoimmunotherapy OR iii. Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference
Subjects in cohort 2 (FL) must meet the following inclusion criteria:
a. Subjects must fit one of the following diagnoses: i. Follicular lymphoma ii. Marginal zone lymphoma b. Disease status must have relapsed after 2 or more lines of therapy
ECOG Performance status ≤ 2.
Participants must exhibit measurable disease with at least one FDG avid lesion at enrollment per Lugano Criteria
Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
Total bilirubin ≤ 1.5X institutional upper limit of normal.
AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal.
Calculated creatinine clearance ≥ 30mL/min estimated by the Cockcroft - Gault formula.
Cardiac ejection fraction of ≥ 45%.
Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 90% on room air.
Subjects (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 90 days after the UF-KURE19 CAR-T cell infusion.
A woman is considered to be of childbearing potential if she is post menarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 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, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
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 for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. 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, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Inclusion of Women and Minorities: Men, women and members of all races and ethnic groups are eligible for this trial.

You may not qualify if…

Inclusion Criteria
Male or female patients aged 18 years or older.
Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.
Subjects in cohort 1 (LBCL) must meet the following inclusion criteria:
a. Subjects must fit one of the following diagnoses: i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) ii. High-grade B-cell lymphoma iii. Primary mediastinal large B-cell lymphoma iv. Follicular lymphoma grade 3B b. LBCL disease status must consist of one of the following: i. Relapsed after 2 or more lines of chemoimmunotherapy OR ii. Disease that is refractory to first line chemoimmunotherapy or relapses within 12 months of completion of initial chemoimmunotherapy OR iii. Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference
Subjects in cohort 2 (FL) must meet the following inclusion criteria:
a. Subjects must fit one of the following diagnoses: i. Follicular lymphoma ii. Marginal zone lymphoma b. Disease status must have relapsed after 2 or more lines of therapy
ECOG Performance status ≤ 2.
Participants must exhibit measurable disease with at least one FDG avid lesion at enrollment per Lugano Criteria
Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.
Total bilirubin ≤ 1.5X institutional upper limit of normal.
AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal.
Calculated creatinine clearance ≥ 30mL/min estimated by the Cockcroft - Gault formula.
Cardiac ejection fraction of ≥ 45%.
Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 90% on room air.
Subjects (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 90 days after the UF-KURE19 CAR-T cell infusion.
A woman is considered to be of childbearing potential if she is post menarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 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, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
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 for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. 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, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Inclusion of Women and Minorities: Men, women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria
Autologous stem cell transplant within 12 weeks of informed consent.
History of allogeneic hematopoietic stem cell transplantation.
Second active malignancy that is not another NHL, other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast), stage 1 uterine cancer, or localized prostate cancer.

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