Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

Open-label, Dose-escalation Phase 1 Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory T-LBL/ALL

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study (NCT06136364) is a Phase 1 interventional studying T-lymphoblastic Lymphoma and T-ALL, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For T-lymphoblastic Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 9 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria: 1. relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears,include: 1. Early recurrence within 12 months, 2. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy, 3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ; 2. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment; 3. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening; 4. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. 5. expected to live at least 12 weeks; 6. ECOG 0-2; 7. Age 18-75 (upper and lower limits included); 8. HGB at least 70g/L,PLT 50x109/L, can be transfused; 9. Liver and kidney functions The cardiopulmonary functions meet the following requirements: 1. Oxygen saturation under air ≥ 92%; 2. LVEF≥50%; 3. Total bilirubin \<3×ULN; 4. ALT/AST\<3×ULN; 5. Creatinine \<1.5×ULN or creatinine clearance rate(Cockroft-Gault)\>50ml/min; 10. willing to sign a consent form explained to, understood by and signed by patient/ guardian. Who Should NOT Join This Trial: Those who meet any of the following criteria are not eligible to join the group: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria: 1. relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears,include: 1. Early recurrence within 12 months, 2. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy, 3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ; 2. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment; 3. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening; 4. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. 5. Life expectancy greater than 12 weeks; 6. ECOG 0-2; 7. Age 18-75 (upper and lower limits included); 8. HGB at least 70g/L,PLT 50x109/L, can be transfused; 9. Liver and kidney functions The cardiopulmonary functions meet the following requirements: 1. Oxygen saturation under air ≥ 92%; 2. LVEF≥50%; 3. Total bilirubin \<3×ULN; 4. ALT/AST\<3×ULN; 5. Creatinine \<1.5×ULN or creatinine clearance rate(Cockroft-Gault)\>50ml/min; 10. Informed consent explained to, understood by and signed by patient/ guardian. Exclusion Criteria: Those who meet any of the following criteria are not eligible to join the group: 1. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \>480ms at screening (QTc interval calculated by Fridericia formula); 2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation; 3. Those with active GvHD or those who require immunosuppressive therapy; 4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ; 5. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy) 6. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections); 7. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years; 8. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded; 9. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer); 10. History of severe allergy to biological products; 11. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy; 12. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion; 13. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening; 14. Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.

Treatments Being Tested

BIOLOGICAL

CAR-T

CAR-T immunotherapy targeting CD7+

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai Ruijin Hospital
Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06136364), the sponsor (Hebei Senlang Biotechnology Inc., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06136364 clinical trial studying?

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06136364?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06136364?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06136364. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06136364. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.