A Clinical Study of CHT101 in CD70-Positive Relapsed or R... | NCT06914037

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

NCT06914037

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Recruiting

Last Update Posted

Apr 6, 2025Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma (CTCL)
NHL (Non-Hodgkin Lymphoma)

Interventions

CHT101

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2025Estimated

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

Mar 30, 2025

First Submission Date that Met QC Criteria

Mar 30, 2025

First Posted Date

Apr 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2025

Last Update Posted Date

Apr 6, 2025Actual

Name	Class
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
CHT101	Experimental	CD70 UCAR-T	Drug: CHT101

Name	Type	Description	Arm Group Labels	Other Names
CHT101	Drug	CD70 UCAR-T	CHT101

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Adverse events post infusion of CHT101 infusion	2 years
Objective response rate (ORR)	The proportion of subjects who achieve CR or PR after CHT101 infusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (abbreviated):

Willing and able to provide written informed consent.
Aged 18 to 70 years, male or female.
Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
1. Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.
2. Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) [stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation]) who have failed ≥2 lines of systemic therapies.
3. Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
4. Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
5. Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Estimated life expectancy ≥12 weeks.
Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.

Exclusion Criteria (abbreviated):

History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
History of solid organ transplantation.
Prior treatment with CD70-targeting agents.
Prior treatment with CAR-T or other cellular/gene therapies.
Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
Active autoimmune disease requiring immunosuppression.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016411	Lymphoma, T-Cell, Peripheral
D016410	Lymphoma, T-Cell, Cutaneous
D008228	Lymphoma, Non-Hodgkin

ID	Term
D016399	Lymphoma, T-Cell
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms