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

NCT05827835 | Recruiting Phase 1

• 1 other identifier: TXB2022023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematologic Diseases; Neoplasms

Keywords

allo-HSCT; CD7 CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence and level of AE and SAE

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

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

Secondary Outcomes (12)

• CAR-T cell expression

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

• CAR-T related cytokine expression

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

• Survival Rate （SR）

  Evaluate at 6, 9, and 12 months

• Time-To-Progression（TTP）

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

• Progression-free survival (PFS)

  Month 6,12,18and 24

Study Arms (1)

Treatment Group

EXPERIMENTAL

R/R CD7+Malignant Hematologic Diseases

Drug: CD7 CAR-T cells injection; Other: Allogeneic hematopoietic stem cell transplantation

Interventions

CD7 CAR-T cells injection DRUG

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

Treatment Group

Allogeneic hematopoietic stem cell transplantation OTHER

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 Group

Eligibility Criteria

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

You may qualify if:

• 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
• According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML
• Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions
• a. No CR after standard chemotherapy
• b. The first induction reaches CR, but CR ≤ 12 months
• c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments
• d. Multiple recurrences
• Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments
• Normal lung function, oxygen saturation greater than 92% without oxygen inhalation
• The blood biochemical test results are consistent with the following results
• a. (AST) and (ALT) ≤ 2.5 × (ULN)
• b. Total bilirubin ≤ 1.5 × ULN

You may not qualify if:

• 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
• Have experienced hypersensitivity or intolerance to any drug used in this study
• Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
• Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening
• Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis
• In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs
• Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding
• Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
• Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
• Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• He Huang, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

+86-0571-87236476; hehuangyu@126.com

Yongxian HU, MD

CONTACT

+86-0571-87236476; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: April 30, 2023
• Primary Completion: April 25, 2026
• Study Completion (Estimated): April 25, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)