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CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

ConditionsHematologic DiseasesNeoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form (ICF)

Male or female, older than 18 years (including 18 years)

Anticipated survival time more than 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Disqualifiers

Patients with the history of epilepsy or other CNS disease

Pregnant or breastfeeding

Active infection with no cure

Patients with prolonged QT interval time or severe heart disease

Trial design

Design model

Single group

Treatments tested in this trial

  • CD7 CAR-T cells injection

    Drug

    CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases

  • Allogeneic hematopoietic stem cell transplantation

    Other intervention

    In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and level of AE and SAE

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Baseline up to 28 days after CD7 CAR T-cells infusion

Secondary outcomes

1

CAR-T cell expression

CAR-T cell expression in vivo

Time frame
Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion
2

CAR-T related cytokine expression

CAR-T related cytokine expression

Time frame
Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion
3

Survival Rate （SR）

Survival Rate （SR）

Time frame
Evaluate at 6, 9, and 12 months
4

Time-To-Progression（TTP）

Time from the beginning of treatment to the progression of the disease

Time frame
Month 2,3,4,6,12,18and 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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