Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rhuFlt3L/CDX-301 · 1 trial · 1 indication
Overall objective response rate at time of best response as defined by International Harmonization (Cheson) Criteria.
| Arm | Type | Description |
|---|---|---|
| rhuFlt3L/CDX-301 | EXPERIMENTAL | intratumoral injections on days 1-5 and 8-11. and Poly-ICLC intratumoral injection weekly, weeks 2-8 |
| Name | Type | Description |
|---|---|---|
| rhuFlt3L/CDX-301 | DRUG | rhuFlt3L/CDX-301 is a truncated, soluble, recombinant human fms-like tyrosine kinase-3 ligand (Flt3L), expressed in a Chinese hamster ovary cell. RhuFlt3L/CDX-301 is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains 2.5 mg/mL rhuFlt3L/CDX-301 in a 1 mL of buffered solution composed of Sodium Phosphate and Sodium Chloride, with a pH of 7. |
| Poly-ICLC | DRUG | Poly-ICLC is supplied by Oncovir in single-dose vials containing 1 mL of 2 mg/mL opalescent white suspension. Each milliliter of Poly-ICLC for injection contains 2 mg/mL poly-IC, 1.5 mg/mL poly-L-lysine, and 5 mg/mL sodium carboxymethylcellulose in 0.9% sodium chloride solution and adjusted to pH 7.6-7.8 with sodium hydroxide. |
Inclusion Criteria: * Biopsy-confirmed low-grade B-cell lymphoma or cutaneous T cell lymphoma; specifically, follicular grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma, or mycosis fungoides of any initial stage. Patients in cohort A must be relapsed/refractory after at least one prio...
rhuFlt3L/CDX-301 is an investigational drug being studied for the treatment of Low-Grade B-cell Lymphoma. It is being evaluated in a Phase 1 clinical trial as part of an in situ vaccine approach, combining intratumoral Flt3L and Poly-ICLC with low-dose radiotherapy.
rhuFlt3L/CDX-301 targets the FMS-like tyrosine kinase 3 (Flt3) receptor. It is a ligand for Flt3, which plays a role in the proliferation and differentiation of hematopoietic cells, including dendritic cells, which are important for immune responses.
rhuFlt3L/CDX-301 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX.
rhuFlt3L/CDX-301 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial for Low-Grade B-cell Lymphoma has been completed.
rhuFlt3L/CDX-301 has been studied in one completed Phase 1 clinical trial, identified as NCT01976585. The trial, titled "In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy," enrolled 21 participants in the United States.
Yes, rhuFlt3L/CDX-301 is also known as CDX-301. The drug is a recombinant human Flt3 ligand being developed by Celldex Therapeutics for oncology indications.