A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies

Phase 1

Recruiting

• Conditions: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma (CTCL); NHL (Non-Hodgkin Lymphoma)
• Interventions: Drug: CHT101

• Registration Number: NCT06914037
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

Detailed Description

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study Start: 2025-03-31
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHT101	CHT101	CD70 UCAR-T

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	28 days of first infusion of CHT101	Safety
Maximum tolerated dose (MTD)	28 days of first infusion of CHT101	Tolerability

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	2 years	Adverse events post infusion of CHT101 infusion
Objective response rate (ORR)	2 years	The proportion of subjects who achieve CR or PR after CHT101 infusion
Duration of response (DOR)	2 years	The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Progression-free survival (PFS)	2 years	The period from the day when the subject receives the infusion of cells to the first recorded tumor progression or death of any cause, which occurs first
Overall survival (OS)	2 years	The period from the first infusion to any cause of death
Pharmacokinetics (PK)	2 years	Concentration levels of CHT101
Pharmacodynamics (PD)	2 years	Concentration levels of cytokines

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China