Study of Metabolically Programmed CAR T-cells for Lymphoma and Leukemia
This study is testing a new type of CAR T-cell therapy called "CD19-CD34t metabolically programmed CAR transduced T-cells" for adults with certain types of B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that have returned or not responded to previous treatments. Before receiving the CAR T-cells, you would receive chemotherapy with Cyclophosphamide and Fludarabine. Researchers hope this new CAR T-cell therapy will be safer and more effective than current options. The study will look at the highest safe dose and how often side effects like cytokine release syndrome (CRS) and ICANS (a type of brain-related side effect) occur. This study is currently unclear about its recruitment status and plans to enroll 27 participants.
- Study design
- This is a single-center study where all participants receive the treatment, and it is not blinded (meaning both you and the study team know what treatment you are receiving). It is a dose-escalation study, meaning different groups of participants will receive increasing doses of the treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects like CRS and ICANS for up to 24 months, and evaluate the treatment's effectiveness for 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05702853
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
Recruiting
PHASE1Ages 18+InterventionalTreatmentMedical University of South CarolinaInvestigator-initiated
~27 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Cyclophosphamide injectionFludarabine InjectionCD19-CD34t metabolically programmed CAR transduced T-cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD/MAD/RP2D evaluation
Measured over 12 months
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesSouth Carolina1
Study leadership
- Brian Hess, PHD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
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
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
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.
What this trial measures
- MTD/MAD/RP2D evaluation12 months
Maximum tolerated dose (MTD), maximum administered dose (MAD) and the recommended phase 2 dose (RP2D) of CD19-CD34t metabolically programmed CAR T-cells
- CRS occurrence evaluationDuration of study, up to 24 months
Rate of grade 3 or higher cytokine release syndrome(CRS)
- ICANS occurrence evaluationDuration of study, up to 24 months
rate of grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS)