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Hematologic DiseasesPhase 1/2NCT05827835

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

A Phase 1/2 study testing CD7 CAR-T cells injection and Allogeneic hematopoietic stem cell transplantation in people with Hematologic Diseases and Neoplasms, run by Zhejiang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Diseases, Neoplasms
What is being tested?
CD7 CAR-T cells injection and Allogeneic hematopoietic stem cell transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 Apr 2023to 25 Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • c. 24-hour serum creatinine clearance ≥ 30 mL/min
  • d. Lipase and amylase ≤ 2 × ULN
  • Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

He Huang, MD contact

+86-0571-87236476

hehuangyu@126.com

Yongxian HU, MD contact

+86-0571-87236476

huyongxian2000@aliyun.com

China1 site, 1 recruiting

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310003

    He Huang, MD, 86-13605714822, hehuangyu@126.com

    Yongxian Hu, MD, +8615957162012, huyongxian2000@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases

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

Being tested
CD7 CAR-T cells injection, Allogeneic hematopoietic stem cell transplantation
Keywords
allo-HSCT, CD7 CAR-T
Medical subject headings
Hematologic Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD7 CAR-T cells injectionDrug

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

  • Allogeneic hematopoietic stem cell transplantationOther

    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

Study groups in NCT05827835
Study groupRoleWhat they receive
Treatment GroupExperimentalR/R CD7+Malignant Hematologic Diseases
Receives: Drug: CD7 CAR-T cells injection; Other: Allogeneic hematopoietic stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and level of AE and SAE

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

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

Secondary outcomes (12)

  1. CAR-T cell expression

    CAR-T cell expression in vivo

    Measured: 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

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

  3. Survival Rate （SR）

    Survival Rate （SR）

    Measured: Evaluate at 6, 9, and 12 months

  4. Time-To-Progression（TTP）

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

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

  5. Progression-free survival (PFS)

    Assessment of PFS at Month 6,12,18and 24

    Measured: Month 6,12,18and 24

  6. Duration of remission,DOR

    The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion

    Measured: Up to 1 years after Treatment

  7. Overall response rate,ORR

    The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).

    Measured: Evaluate at 4, 8, and 12 weeks after CAR-T infusion

  8. Clinical Benefit Rate（CBR）

    ORR+MR

    Measured: Up to 24 weeks after Treatment

  9. Disease Control Rate （DCR）

    CBR+SD

    Measured: Up to 12 weeks after Treatment

  10. Overall survival, OS

    The time from CAR-T infusion to death due to any cause

    Measured: Up to 1 years after Treatment

  11. Minimal Residual Disease

    MRD in CR and sCR patients

    Measured: Up to 2 years after Treatment

  12. Bone marrow transplantation STR

    Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR

    Measured: Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start30 Apr 2023
  3. Primary completion25 Apr 2026 (estimated)
  4. Study completion25 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827835
Sponsor's protocol ID
TXB2022023
Status last verified
Aug 2025
First submitted
30 Mar 2023
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD7 CAR-T cells injection and Allogeneic hematopoietic stem cell transplantation in people with Hematologic Diseases and Neoplasms, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact He Huang, MD (+86-0571-87236476, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and level of AE and SAE (time frame: Baseline up to 28 days after CD7 CAR T-cells infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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