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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL

A Phase 1b Dose Escalation Study of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers in Adult Patients With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL (NCT05702853) is a Phase 1 / Phase 2 interventional studying B-cell Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, sponsored by Medical University of South Carolina. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B-cell Non Hodgkin Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Patients eligible for study participation must meet all of the following criteria: 1. Disease Related Criteria Participants must have histologic confirmation of one of the following: 1. CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes - Diffuse Large B-cell Lymphoma, not otherwise specified - DLBCL, germinal-center B-cell type (GCB) - DLBCL, activated B-cell type (ABC) - T-cell histiocyte-rich B-cell lymphomas (THRBCL) - Primary cutaneous DLBCL, leg type - Intravascular large B cell lymphoma - EBV+ DLBCL, NOS - DLBCL associated with chronic inflammation - HHV8+ DLBCL, NOS - High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement(double hit lymphoma) - High grade B-cell lymphoma, NOS - Primary mediastinal B-cell lymphoma - B-cell Lymphoma, unclassifiable with features intermediate between DLBCL and Hodgkin lymphoma, as well as with features intermediate between DLBCL and Burkitt lymphoma - Follicular lymphoma grade 3B - Transformation of indolent lymphoma (i.e. CLL, MZL, FL, Waldenstrom's lymphoma,etc) to -diffuse large B-cell lymphoma - Burkitt Lymphoma - Lymphomatoid granulomatosis 2. CD19+ indolent non-Hodgkin lymphoma including any of the following subtypes: - Follicular lymphoma (grade 1-3A) - Marginal zone lymphoma: Including splenic marginal zone lymphoma, nodal marginal zone lymphoma, and mucosa associated lymphoid tissue (MALT) lymphoma - Waldenstrom's Macrogloublinemia - Nodular lymphocyte predominant hodgkin lymphoma (with documented CD19 expression) 3. Mantle cell Lymphoma 4. Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) 2. Prior Therapy Criteria Prior/Concurrent Therapy Related Criteria (dependent upon subtype - see below) 1. Aggressive lymphoma: patients will qualify if any of the following scenarios are met below (radiation does not count as a line of therapy) - Relapse or persistent disease after ≥ 2 lines of systemic therapy OR ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Patients eligible for study participation must meet all of the following criteria: 1. Disease Related Criteria Participants must have histologic confirmation of one of the following: 1. CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes * Diffuse Large B-cell Lymphoma, not otherwise specified * DLBCL, germinal-center B-cell type (GCB) * DLBCL, activated B-cell type (ABC) * T-cell histiocyte-rich B-cell lymphomas (THRBCL) * Primary cutaneous DLBCL, leg type * Intravascular large B cell lymphoma * EBV+ DLBCL, NOS * DLBCL associated with chronic inflammation * HHV8+ DLBCL, NOS * High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement(double hit lymphoma) * High grade B-cell lymphoma, NOS * Primary mediastinal B-cell lymphoma * B-cell Lymphoma, unclassifiable with features intermediate between DLBCL and Hodgkin lymphoma, as well as with features intermediate between DLBCL and Burkitt lymphoma * Follicular lymphoma grade 3B * Transformation of indolent lymphoma (i.e. CLL, MZL, FL, Waldenstrom's lymphoma,etc) to -diffuse large B-cell lymphoma * Burkitt Lymphoma * Lymphomatoid granulomatosis 2. CD19+ indolent non-Hodgkin lymphoma including any of the following subtypes: * Follicular lymphoma (grade 1-3A) * Marginal zone lymphoma: Including splenic marginal zone lymphoma, nodal marginal zone lymphoma, and mucosa associated lymphoid tissue (MALT) lymphoma * Waldenstrom's Macrogloublinemia * Nodular lymphocyte predominant hodgkin lymphoma (with documented CD19 expression) 3. Mantle cell Lymphoma 4. Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) 2. Prior Therapy Criteria Prior/Concurrent Therapy Related Criteria (dependent upon subtype - see below) 1. Aggressive lymphoma: patients will qualify if any of the following scenarios are met below (radiation does not count as a line of therapy) * Relapse or persistent disease after ≥ 2 lines of systemic therapy OR * Refractory disease or relapse within 12 months of completion of 1st line systemic therapy OR * Refractory disease or relapse ≥ 1 line of therapy but not a candidate for autologous stem cell transplant * Patients with Burkitt lymphoma will qualify after ≥ 1 line of therapy regardless of the timing of relapse 2. Indolent lymphoma: * Relapse or persistent disease after ≥ 2 lines of systemic therapy. (Neither single agent rituximab or radiation qualify as a line of therapy.) 3. Mantle cell lymphoma: * Relapse or persistent disease after ≥ 1 line of systemic therapy. Neither single agent rituximab or radiation qualify as a line of therapy. 4. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma * Evidence of progression or intolerance after ≥ 2 lines of therapy. The following will qualify as a line of therapy for CLL/SLL: * systemic chemoimmunotherapy (e.g. BR, FCR, etc), * BTK inhibitor, BCL-2 inhibitor, * or PI3 Kinase inhibitor. * Neither single agent rituximab/obinutuzumab or radiation qualify as a line of therapy. 3. Clinical/Laboratory Criteria 1. Participants must be at least 18 years old 2. Participants must have a performance status of 0-2 on the ECOG scale 3. Participants must have adequate caregiving support for CAR T-cell therapy as determined by the PI/Co-I. 4. Participants must have measurable disease on cross section imaging by PET-CT and/or CT scans alone that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria. If participants with CLL do not have measurable disease on imaging, a bone marrow biopsy showing \> 5% CLL involvement in the bone marrow will qualify for enrollment 5. Participants that have received prior CD19 targeted therapy in the past they must have a tissue biopsy after completion of CD19 targeted therapy noting CD19 expression by either flowcytometry or immunohistochemistry (IHC). CD19 expression must be sufficient per PI/Co-I 6. Adequate organ function * Bone marrow function as evidenced by the following (unless directly attributable to disease within the bone marrow) within 14 days prior to registration. * Platelet count ≥ 50,000 cells/mm3 * ANC ≥ 750 cells/mm3 * Absolute lymphocyte count ≥ 150 cells/ mm3 * Hepatic function as evidenced by the following within 14 days prior to registration. * Serum bilirubin ≤ 1.5 X ULN unless attributed to Gilbert's syndrome or hemolysis or lymphoma involvement * Cardiac * No clinically significant ECG findings per PI/Co-I * Pulmonary * Oxygen saturation \> 90% on room air * Renal function as evidenced by the following within 14 days prior to registration. * Serum creatinine ≤ 2 mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min 7. Participants with hepatitis B virus infection must have undetectable viral load and on suppressive therapy within 14 days prior to registration and no evidence of HBV related hepatic damage. 8. Participants with Hepatitis C infection must have complete eradication therapy completed, have no evidence of HCV related damage and have undetectable viral load within 14 days of registration. 9. Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti- retroviral therapy and have an undetectable viral load test within 14 days prior to registration. 10. WOCBP should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below. FCBP must have negative serum or urine pregnancy within 7 days prior to registration. 11. Men with female partners who are of childbearing potential: Recommendations for male and partner to use at least two effective contraceptive methods, as described above, during the study. 12. Participants are able to understand and voluntarily sign consent prior to any study related assessments or procedures are performed. Exclusion Criteria: Participants eligible for study participation CANNOT meet any of the following criteria: 1. Prior/Concurrent Therapy Related Criteria Guidelines regarding when lymphoma directed therapy should be stopped prior to leukapheresis, lymphodepleting chemotherapy, and CAR T-cell infusion are detailed in the protocol. These criteria must be planned to be met for all patients. 2. Clinical/Laboratory Criteria 1. Women who are pregnant or breast-feeding. 2. Participants with active CNS lymphoma. Participants can have a history of active CNS lymphoma as outline in protocol 3. Participants with evidence of Graft vs Host Disease from allogeneic stem cell transplant are ineligible unless it is either grade 1 involvement of the skin or not requiring systemic immunosuppression. 4. Participants with uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment) 5. Participants with a history of stroke or intracranial hemorrhage within 6 months prior to registration. Any CNS disorder that would serve as a major barrier in evaluating neurotoxicity/ICANS per enrolling physician 6. Participants with prior history of malignancy other than lymphoma unless subject is free of disease for more than 1 year from signing consent. Exceptions include the following: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix or breast * Previously treated localized prostate cancer with normal PSA levels 7. Participants with primary immunodeficiency or history of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 1 year. 8. Participants with receipt of live vaccine within 28 days prior to registration. 9. Participants with history of autologous stem cell transplant within the last 60 days or allogeneic stem cell transplant within the last 90 days or CAR T-cell therapy within the last 180 days. 10. Participants with a history of severe immediate hypersensitivity reaction to any of the agents used in the study 11. Participants with any other illness that in the opinion of the investigator, would exclude the patient from participating in this study. 12. Participants must not have evidence of active CNS lymphoma involvement. This includes parenchymal, spinal cord, meningeal, or cerebrospinal fluid involvement. Patients with history of CNS involvement must have documented remission by contrast-enhanced MRI imaging and CSF evaluation for at least 60 days prior to registration. 13. Patients must not have any unstable angina, or myocardial infarction within the last 6 months, or symptoms consistent with NYHA CHF classification III or IV 14. Participants with receipt of live vaccine within 28 days prior to registration. 15. Participants with history of autologous stem cell transplant within the last 60 days or allogeneic stem cell transplant within the last 90 days or CAR T-cell therapy within the last 180days. 16. Participants with a history of severe immediate hypersensitivity reaction to any of the agents used in the study 17. Participants with any other illness that in the opinion of the investigator, would exclude the patient from participating in this study.

Treatments Being Tested

DRUG

Cyclophosphamide injection

500 mg/m2 IV over 30-60 minutes +/- 10 minutes before Fludarabine Days -5, -4, - 3

DRUG

Fludarabine Injection

30 mg/m2 IV over 30-60 minutes +/- 10 minutes after cyclo- phosphamide infusion Days -5, 4, -3

BIOLOGICAL

CD19-CD34t metabolically programmed CAR transduced T-cells

Cells are to be infused intravenously (IV) over 30 minutes or less via nonfiltered tubing either by gravity or a peristaltic pump, gently agitating the bag during infusion to prevent cell clumping

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05702853), the sponsor (Medical University of South Carolina), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05702853 clinical trial studying?

This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05702853?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05702853?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05702853. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05702853. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.