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HH2853

Phase 1

Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL) | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06909877Study to Evaluate Efficacy and Safety of HH2853 in Relapsed/Refractory Peripheral T-cell LymphomaPHASE1 RECRUITING 100 — — Jul 27, 2022Jul 30, 2027Jan 30, 20261 China
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Study Endpoints
Primary Endpoints
Phase Ib: To determine the RP2D of HH2853 in PTCL patients
28-day treatment cycles

Determine RP2D of HH2853

Phase II: To evaluate the efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug
28-day treatment cycles

ORR will be based on the blinded independent review committee (BIRC). Assessment of oncologic response will be performed according to the 2014 edition of the Lugano Criteria for Efficacy \[Lugano\]

Secondary Endpoints
Phase Ib: 1. Preliminary efficacy of HH2853 in R/R PTCL patients;
28-day treatment cycles
Phase Ib: 2.To characterize the pharmacokinetic profile of HH2853
28-day treatment cycles
Phase II: 1.To further assess the other efficacy of HH2853 of R/R PTCL patients who have received at least one prior systemic combination chemotherapy and at least one new drug (such as Chidamide, Pralatrexate and Brentuximab vedotin, et al.) therapy
28-day treatment cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalation and expansion study of HH2853EXPERIMENTALTo determine the RP2D of HH2853 in PTCL patients.
Interventions
NameTypeDescription
HH2853 TabletsDRUG25mg, 100mg and 200 mg BID oral administration
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * main inclusion: 1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase I...

Countries:China
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