Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
Paolo Caimi, MD
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07225439CT.gov Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) | — | Not Yet Recruiting | — | — | — |
NCT07259070CT.gov Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma | — | Recruiting | — | — | — |
NCT07024147CT.gov JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma | — | Not Yet Recruiting | — | — | — |
NCT05077527CT.gov Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma | — | Recruiting | — | — | — |
NCT06343376CT.gov Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies | — | Terminated | — | — | — |
NCT07168486CT.gov CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas | — | Enrolling By Invitation | — | — | — |
NCT06550141CT.gov Emapalumab Prevention of CAR-T Cell Associated Toxicities | — | Recruiting | — | — | — |
NCT06313996CT.gov A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma | — | Withdrawn | — | — | — |
NCT06191887CT.gov B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies | — | Recruiting | — | — | — |
NCT06043323CT.gov A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma | — | Recruiting | — | — | — |
Show 62 more trialsShow fewer
NCT06093841CT.gov Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL | — | Active Not Recruiting | — | — | — |
NCT06026319CT.gov CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma | — | Recruiting | — | — | — |
NCT05888493CT.gov A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma | — | Active Not Recruiting | — | — | — |
NCT05633615CT.gov Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma | — | Recruiting | — | — | — |
NCT05805605CT.gov Allo HSCT Using RIC and PTCy for Hematological Diseases | — | Recruiting | — | — | — |
NCT05665062CT.gov Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies | — | Active Not Recruiting | — | — | — |
NCT05583149CT.gov Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas | — | Active Not Recruiting | — | — | — |
NCT05653271CT.gov ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies | — | Active Not Recruiting | — | — | — |
NCT05359211CT.gov NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma | — | Active Not Recruiting | — | — | — |
NCT05371093CT.gov Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma | — | Active Not Recruiting | — | — | — |
NCT05020392CT.gov Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma | — | Unknown | — | — | — |
NCT04735471CT.gov A Phase 1 Study of ADI-001 in B Cell Malignancies | — | Terminated | — | — | — |
NCT04844086CT.gov RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies | — | Terminated | — | — | — |
NCT04836507CT.gov Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients | — | Recruiting | — | — | — |
NCT04767308CT.gov Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies | — | Unknown | — | — | — |
NCT04195633CT.gov Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | — | Recruiting | — | — | — |
NCT04223765CT.gov Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. | — | Recruiting | — | — | — |
NCT04545762CT.gov Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma | — | Recruiting | — | — | — |
NCT04323657CT.gov TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT04049513CT.gov ENABLE-1 (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy) | — | Active Not Recruiting | — | — | — |
NCT04007029CT.gov Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia | — | Active Not Recruiting | — | — | — |
NCT04088890CT.gov Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies | — | Completed | — | — | — |
NCT03622788CT.gov Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant | — | Active Not Recruiting | — | — | — |
NCT03939026CT.gov Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma | — | Completed | — | — | — |
NCT03676504CT.gov Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR | — | Recruiting | — | — | — |
NCT03314974CT.gov Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders | — | Recruiting | — | — | — |
NCT03277729CT.gov A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas | — | Active Not Recruiting | — | — | — |
NCT03105336CT.gov A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma | — | Completed | — | — | — |
NCT02722668CT.gov UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep | — | Completed | — | — | — |
NCT02661035CT.gov Allo HSCT Using RIC for Hematological Diseases | — | Completed | — | — | — |
NCT01962636CT.gov Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases | — | Terminated | — | — | — |
NCT02685670CT.gov Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma | — | Unknown | — | — | — |
NCT02348216CT.gov Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma | — | Completed | — | — | — |
NCT02153580CT.gov Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia | — | Active Not Recruiting | — | — | — |
NCT01163201CT.gov T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies | — | Withdrawn | — | — | — |
NCT01760655CT.gov Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies | — | Completed | — | — | — |
NCT01597778CT.gov Double Cord Versus Haploidentical (BMT CTN 1101) | — | Completed | — | — | — |
NCT01384513CT.gov A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies | — | Completed | — | — | — |
NCT01658319CT.gov Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies | — | Completed | — | — | — |
NCT01208896CT.gov Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma | — | Completed | — | — | — |
NCT01044745CT.gov Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer | — | Terminated | — | — | — |
NCT00850499CT.gov Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab | — | Terminated | — | — | — |
NCT00942409CT.gov Study of Repeat Intranodal Injections of Ad-ISF35 | — | Terminated | — | — | — |
NCT00864227CT.gov Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604) | — | Completed | — | — | — |
NCT00849147CT.gov Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603) | — | Completed | — | — | — |
NCT00562965CT.gov Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL) | — | Terminated | — | — | — |
NCT00621452CT.gov Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma | — | Completed | — | — | — |
NCT00510887CT.gov Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma | — | Terminated | — | — | — |
NCT00536601CT.gov High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | — | Completed | — | — | — |
NCT00774826CT.gov Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma | — | Unknown | — | — | — |
NCT00719888CT.gov Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease | — | Completed | — | — | — |
NCT00118352CT.gov Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00105001CT.gov Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00096460CT.gov Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202) | — | Terminated | — | — | — |
NCT00079443CT.gov FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma | — | Terminated | — | — | — |
NCT00058227CT.gov Alvocidib, Fludarabine Phosphate, and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma | — | Completed | — | — | — |
NCT00060684CT.gov Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma | — | Completed | — | — | — |
NCT00169208CT.gov Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma | — | Completed | — | — | — |
NCT00006251CT.gov Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer | — | Completed | — | — | — |
NCT00393107CT.gov Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab | — | Completed | — | — | — |
NCT00005799CT.gov Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer | — | Completed | — | — | — |
NCT00859001CT.gov Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Follicular Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fludarabine (this asset) | Paolo Caimi, MD | P3 | BB · 65 |
| Cyclosporin A | Fred Hutchinson Cancer Center | P2/3 | BBB |
| Romidepsin | City of Hope Medical Center | P2 | BBB |
| Busulfanum | Masonic Cancer Center, University of Minnesota | P2/3 | BBB |
| Recombinant Human Hyaluronidase | National Cancer Institute (NCI) | P3 | BBB |
| Vincristine Sulfate | National Cancer Institute (NCI) | P3 | BBB |
| Irinotecan | University of Michigan Rogel Cancer Center | P2 | BBB |
| Bortezomib | Emory University | P2 | BB |
| Rituximab | Sun Yat-sen University | P4 | BB |
+42 more in the Follicular Lymphoma cohort
Other indications for Fludarabine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult T-Cell Leukemia/Lymphoma | — | P2 | BBB · 76 |
| Acute Myeloid Leukemia With Abnormal Bone Marrow Eosinophils Inv(16)(P13q22) Or T(16;16)(P13;Q22) | — | P2 | BBB · 76 |
| Fanconi Anemia | — | P2/3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fludarabine in Follicular Lymphoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 9, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fludarabine-follicular-lymphoma-3333
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