A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

This is a single-center, single-arm ,open-label ,dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and sign a written informed consent documen;

Age ≥18 years old, male or female;

Histopathological confirmed advanced or metastatic solid tumors failed to at least second-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy;

Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 2+) confirmed by histology or pathology));

Disqualifiers

Received anti-CD70 drug treatment before screening;

Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is longer) before Received;

Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to Received;

Pregnant, lactating, or breastfeeding females;

Trial design

Design model

Single group

Treatments tested in this trial

  • CHT101

    Drug

    After lymphodepletion with Fludarabine and Cyclophosphamide, CD70 UCAR T cells were transfused intravenously.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Anti-CD70 UCAR-T Cell InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability)

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Time frame
28 days

Secondary outcomes

1

Disease control rate (DCR)

The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria),the minimum value is 0%,maximum value is 100%, and higher scores mean a better outcome.

Time frame
42 days
2

Objective response rate (ORR)

The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria),the minimum value is 0%,maximum value is 100%, and higher scores mean a better outcome.

Time frame
42 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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