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

NCT07713459 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HEM01
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Can UF-KURE19 achieve a CRR of ≥ 60% in patients with relapsed/refractory Follicular or Marginal Zone Lymphoma at Day 90 post-infusion?
3. 3.Undergo leukapheresis for collection of their own T cells, which will be used to manufacture UF-KURE19.
4. 4.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
5. 5.Undergo safety monitoring including adverse event collection, laboratory tests, neurological exams, CAR-T persistence assays, and replication-competent lentivirus (RCL) testing throughout the study
6. 6.Be followed long-term for up to 15 years post-infusion for gene therapy safety surveillance per FDA requirements

Conditions

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

Keywords

CAR T-cell; Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Objective and Complete Response rates per Lugano Revised Response Criteria for R/R B-cell NHL

  Day 90 after infusion of UF-KURE19 CAR-T cells

Secondary Outcomes (5)

• Duration of CR

  12 and 24 months after infusion of UF-KURE19 CAR-T cells

• Overall Survival

  At 12 and 24 months

• Progression-Free Survival (PFS)

  12 and 24 months

• Manufacturing Success Rate

  28 days post infusion

• To evaluate adverse events associated to the administration of UF-KURE19

  At 3 and 6 months post CART-cell infusion

Study Arms (2)

DLBCL Arm

EXPERIMENTAL

This Cohort will include patients with Diffuse Large B-cell lymphoma (DLBCL)

Biological: CART Infusion

Non-DLBCL Arm

EXPERIMENTAL

This cohort will include patients with: Follicular Lymphoma (FC) and Marginal Zone Lymphoma (MZL)

Biological: CART Infusion

Interventions

CART Infusion BIOLOGICAL

UF-KURE19 are CD19 CAR-T cells that are manufactured using an Ultra-fast less than 1 day process

DLBCL Arm; Non-DLBCL Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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
• 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.

You may not 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.
• 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
• 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.

Sponsors & Collaborators

• Kure Cells, INC: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Central Study Contacts

Daniel Couriel, MD, MS, MBA

CONTACT

7343539036; daniel@cellserveglobal.net

Ola Soliman, MD

CONTACT

647-865-0773; olaselkadi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single arm study with 2 cohorts: 81 participants in Cohort 1: Large B-Cell Lymphoma (LBCL) 24 participants in Cohort 2: Follicular Lymphoma (FC) and Marginal Zone Lymphoma (MZL)

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share