Actively Recruiting
A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells in Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoma (T-ALL/NHL): The CONQUER Trial
Led by Peking University People's Hospital · Updated on 2026-05-07
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
H
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of Nanobody-Based CD5 Chimeric Antigen Receptor (CAR) T-cell therapy in treating patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma (T-NHL). This Phase I/II trial addresses the urgent need for new treatment options in these conditions by studying this novel immunotherapy approach. In Phase I, patients will receive a single infusion of CD5-targeted CAR-T cells at increasing doses to determine the safest and most effective dose using a 3+3 dose-escalation design. Following chemotherapy with fludarabine and cyclophosphamide to prepare the body, Phase II will treat patients at the recommended Phase II dose (RP2D) established from the first phase. The study focuses on monitoring safety and response to treatment. Participants will be closely observed for side effects, especially cytokine release syndrome and neurotoxicity, and their response to therapy will be assessed through measures such as dose-limiting toxicity and overall response rate within 3 months. Long-term outcomes like progression-free and overall survival will also be tracked up to 2 years. The study includes ongoing safety evaluations and requires participants to meet specific health criteria to join and remain in the trial.
CONDITIONS
Brief Title
Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject or guardian understands and voluntarily signs the informed consent form.
- Male or female, aged 3 to 70 years at the time of consent.
- Expected survival of at least 12 weeks.
- ECOG performance status of 0 to 2.
- Diagnosis of relapsed or refractory T-cell lymphoblastic leukemia/lymphoma confirmed at screening.
- Disease involvement including bone marrow lymphoblasts ≥5%, CSF tumor cells, or measurable extramedullary lesions.
- CD5-positive tumor cells by flow cytometry or pathology.
- Adequate organ function: AST and ALT ≤5 times upper limit of normal, total bilirubin ≤2 times upper limit, serum creatinine clearance ≥60 mL/min or creatinine ≤1.5 times upper limit.
- Blood oxygen saturation greater than 92%.
- Fertile men and women of childbearing potential must use effective contraception during and for 2 years after treatment.
- Negative pregnancy test for women of childbearing potential at screening.
You will not qualify if you...
- History of central nervous system diseases such as epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or neuropathy.
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years, including Crohn's disease, rheumatoid arthritis, lupus, systemic sclerosis, inflammatory bowel disease, vasculitis, or psoriasis.
- Uncontrolled active infection requiring treatment at screening or within 4 weeks prior to apheresis.
- Positive markers for hepatitis B, hepatitis C, HIV, cytomegalovirus, Epstein-Barr virus, or syphilis without controlled status.
- Significant cardiovascular diseases including prolonged QTc interval, heart failure class II or higher, recent unstable angina or heart attack, reduced heart function, poorly controlled hypertension, or serious arrhythmias.
- Severe allergy to components of the study drug.
- Recent investigational or systemic antitumor therapy within 4 weeks before apheresis.
- Recent extensive radiotherapy within 4 weeks before consent.
- Unresolved toxicity from prior therapy except hair loss or pigmentation.
- Systemic corticosteroid or immunosuppressive therapy exceeding specified limits within 3 days prior to apheresis or during the study, except certain low-dose or localized uses.
- Major surgery within 4 weeks prior to consent or planned during the study.
- Active tuberculosis infection within 1 year prior to consent.
- Other primary cancers within 5 years, except certain treated skin or cervical cancers.
- Recent live or inactivated vaccinations within 4 weeks before consent or planned during screening.
- Any condition that may interfere with study adherence or suitability.
- Pregnancy or lactation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Single infusion with assessments through Day 28
Participants receive lymphodepleting chemotherapy followed by a single infusion of CD5-targeted CAR-T cells at assigned dose levels in Phase I or at the recommended Phase II dose.
1 baseline visit and multiple visits for safety monitoring up to Day 28 after infusion
Duration - Up to 2 years after CAR-T cell infusion
Participants are monitored for safety and efficacy outcomes including response rates, progression-free survival, and overall survival.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
M
MENG LV, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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