Trials Sponsors Conditions Drugs Pricing

Conditions

T-cell Acute Lymphoblastic Leukemia/Lymphoma

Keywords

T-ALL，T-LBL , CD7，CAR-T

Outcome Measures

Primary Outcomes (2)

Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within the first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
First 1 month post CAR-T cells infusion
Efficacy: Remission Rate
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR)
3 months post CAR-T cells infusion

Secondary Outcomes (7)

duration of response (DOR)
24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
24 months post CAR-T cells infusion
CAR-T proliferation
3 months post CAR-T cells infusion
CAR-T proliferation
3 months post CAR-T cells infusion
Cytokine release
First 1 month post CAR-T cells infusion
+2 more secondary outcomes

Study Arms (1)

CD7 CAR-T

EXPERIMENTAL

Patients will be treated with CD7 CAR-T cells

Biological: CD7 CAR-T

Interventions

CD7 CAR-TBiological

Patients will be treated with CD7 CAR-T cells Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

CD7 CAR-T

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patients whose tumor burden \>5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible.

Sponsors & Collaborators

Hebei Senlang Biotechnology Inc., Ltd.
Industrylead

Study Sites (1)

Hebei yanda Ludaopei Hospital

Yanda, Hebei, China

Related Publications (2)

Cao XY, Zhang JP, Wei ZJ, Lu Y, Zhao YL, Xiong M, Zhou JR, Wang Y, Yang JF, Zhang X, Li J, Lu P. Long-Term Outcomes of Second Allogeneic Transplantation Following CD7 CAR-T in Remission for T-Cell Acute Lymphoblastic Leukemia or Lymphoma. Transplant Cell Ther. 2026 Aug;32(8):956.e1-956.e13. doi: 10.1016/j.jtct.2026.05.045. Epub 2026 Jun 1.
PMID: 42229585DERIVED
Velasquez MP. Allogeneic CD7-CAR T cells to bridge the gap? Transplant Cell Ther. 2023 Mar;29(3):139-140. doi: 10.1016/j.jtct.2023.02.006. No abstract available.
PMID: 36858787DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 1, 2020

Study Start

October 1, 2020

Actual (reported)

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

CD7 CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

CD7 CAR-T

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations