A Clinical Study to Evaluate CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematologic Malignancies

NCT07809139 | Not Yet Recruiting Phase 1

• 1 other identifier: CHT101HIIT-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of anti-CD70 chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies. Secondary Objectives: To characterize the PK profiles of CHT101; to evaluate the clinical efficacy of CHT101 for CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies. Indication: CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies

Conditions

Hematological Malignancies

Keywords

UCAR-T

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  Day 28

• To assess the incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs).

  Throughout the study period, up to 24 months

Secondary Outcomes (6)

• Peripheral blood CAR-T cell proportion

  Day 1,Day 2,Day 4,Day 7,Day 11,Day 14,Day 18,Day 21,Day 28,Month 2,Month 3,Month 4,Month 5,Month 6,Month 9,Month 12,Month 15,Month 18,Month 21,Month 24

• ORR

  Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

• DOR

  Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

• PFS

  Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

• OS

  Month 2,Month 3,Month 6,Month 9,Month 12,Month 18,Month 24

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: CHT101

Interventions

CHT101 DRUG

Single-dose and multiple-dose administration Method of Administration: Intravenous infusion Dose of Administration:3.6\*10\^9 CAR-T cells,7.2\*10\^9 CAR-T cells,10\*10\^9 CAR-T cells.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily provide written informed consent (ICF) prior to any study-related assessments/procedures;
• Aged between 18 and 70 years (inclusive) at the time of ICF signing;
• CD70-positive tumor cells detected in bone marrow or peripheral blood by flow cytometry, or positive CD70 immunohistochemistry in tumor tissue;
• Subjects with relapsed/refractory T-cell malignancies with measurable disease as defined by modified Severity-Weighted Assessment Tool (mSWAT) score or peripheral blood tumor burden, or at least one measurable lesion identified by imaging (PET-CT or CT) according to Lugano criteria (lymph node lesion with any diameter \>1.5 cm; extranodal lesion with any diameter \>1.0 cm), and meeting the following criteria: relapsed/refractory peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, adult T-cell leukemia/lymphoma) or cutaneous T-cell lymphoma (including but not limited to mycosis fungoides or Sézary syndrome \[stage IIB or higher with disease involving two or more regions, or single-region disease with large-cell transformation\]), and having received prior systemic therapy: subjects with peripheral T-cell lymphoma shall have received at least one line of therapy; subjects with cutaneous T-cell lymphoma shall have received at least two lines of therapy; for anaplastic large-cell lymphoma (ALCL), subjects must have relapsed following prior brentuximab vedotin therapy, or relapsed after ≥2 prior therapies (if anaplastic lymphoma kinase-positive);
• Subjects with relapsed/refractory B-cell malignancies with at least one measurable lesion and meeting at least one of the following criteria:
• Indolent lymphoma (FL, MCL, MZL): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody;
• Chronic lymphocytic leukemia (CLL): relapsed or refractory after at least two prior lines of therapy including BTK inhibitor and venetoclax;
• Aggressive or highly aggressive lymphoma (DLBCL, Burkitt lymphoma, high-grade B-cell lymphoma \[double-hit, triple-hit, primary mediastinal DLBCL\]): relapsed or refractory after at least two prior lines of therapy containing a CD20 antibody and anthracycline, and the subject is ineligible for autologous stem-cell transplantation (conditions for ineligibility for autologous stem-cell transplantation include absence of disease response after salvage therapy, and failure of stem-cell mobilization precluding transplantation);
• Acute lymphoblastic leukemia (ALL): relapsed or refractory after at least two prior lines of therapy;
• Histopathologically confirmed classical Hodgkin lymphoma (cHL), relapsed or refractory (following BV and PD-1 therapy), with at least one measurable lesion per the Lugano 2014 lymphoma response evaluation criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of ICF signing;
• Expected survival of at least 12 weeks;
• Fertile male subjects and female subjects of child-bearing potential must agree to use effective contraception from the time of ICF signing until 2 years after administration of investigational product. Female subjects of child-bearing potential include pre-menopausal women and women within 2 years post-menopause. Serum pregnancy test must be negative for female subjects of child-bearing potential at screening.

You may not qualify if:

• Central nervous system (CNS) metastasis, leptomeningeal disease or metastatic central compression; or prior history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.;
• History of organ transplantation;
• History of other primary malignancies within 5 years prior to study treatment, except for: a) adequately treated and cured carcinoma in situ of the cervix; b) localized basal-cell carcinoma or squamous-cell carcinoma of the skin;
• Subjects with positive HBV DNA in peripheral blood at screening; subjects positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects with both positive treponemal-specific antibody and non-treponemal antibody tests for syphilis;
• Known allergy to any component of study medications, including but not limited to lymphodepleting agents (cyclophosphamide, fludarabine), contrast media for imaging examinations;
• Prior anti-CD70 antitumor therapy, including but not limited to anti-CD70 cell therapy (autologous or allogeneic), TCR-T therapy, etc.;
• Prior receipt of CAR-T therapy or other cell/gene therapy;
• Presence of acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to ICF signing, or receipt of systemic medicinal treatment for GVHD within 4 weeks prior to first infusion;
• Receipt of any investigational product or systemic antitumor therapy within 28 days prior to first infusion (or five half-lives of the drug, whichever is more appropriate at the investigator's discretion);
• Receipt of extensive radiotherapy within 28 days prior to ICF signing, except for local radiotherapy for symptomatic relief of non-target lesions administered within 14 days prior to ICF signing or anticipated during the study period;
• Major surgical procedure within 28 days prior to ICF signing, or anticipated major surgical procedure during the study period;
• Any uncontrolled active infection requiring parenteral antibiotic, antiviral or antifungal therapy at the time of ICF signing or within 4 weeks prior to first infusion;
• History of active pulmonary tuberculosis within 1 year before screening (except for subjects with a history of active pulmonary tuberculosis more than 1 year earlier who are judged by the investigator to have no current evidence of active pulmonary tuberculosis);
• Concurrent or prior history of interstitial lung disease or interstitial pneumonia;
• Active or previously-occurred autoimmune diseases with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk for such diseases;

Sponsors & Collaborators

• Nanjing Miracle Biotechnology Co., Ltd.: lead
• Jiangxi Provincial Cancer Hospital: collaborator

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Chao Dai

CONTACT

15850641905; chao.dai@njmiracle.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)