In vivo CAR‑T treatment targeting BCMA, GPRC5D, DLL3, and FcRH5 for advanced tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, open-label, single-center, dose-escalation Phase I platform trial tests V001, an in vivo CAR‑T lentiviral injection, in cohorts defined by tumor type and target antigen. Patients with relapsed or refractory hematologic malignancies or solid tumors whose tumors express the chosen target (BCMA, GPRC5D, DLL3, or FcRH5) are enrolled into separate cohorts. Primary endpoints are safety and tolerability, with secondary and exploratory endpoints including preliminary anti-tumor activity, pharmacokinetics, and pharmacodynamics. The platform design allows multiple V001 constructs to be tested sequentially using dose-escalation to define recommended doses and early signals of activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Histologically confirmed advanced hematological malignancies (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that are relapsed or refractory.
* Tumor cells express the relevant target (e.g., BCMA, GPRC5D, DLL3) as required for the specific cohort.
* ECOG performance status 0-2 (hematological malignancies) or 0-1 (solid tumors) and life expectancy ≥ 3 months.
* Adequate organ function (e.g., creatinine clearance ≥45 mL/min, LVEF ≥45%).
* Patients of childbearing potential must agree to use effective contraception during the study and for 1 year after dosing.
* Signed informed consent form.

Exclusion Criteria:

* Active, uncontrolled infection.
* Active central nervous system metastases or involvement.
* Prior anticancer therapy, radiotherapy, or investigational therapy within specified timeframes before the first study dose.
* Severe cardiac or pulmonary disease (e.g., NYHA Class III/IV heart failure), severe hepatic or renal impairment.
* Active Hepatitis B, Hepatitis C, HIV, or syphilis infection.
* Prior allogeneic hematopoietic stem cell transplantation (within specified window) or active graft-versus-host disease.
* Pregnancy or lactation.
* History of severe allergy to any components of the investigational product.
* Any other condition deemed by the investigator to increase risk or interfere with study results.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Li Ning, M.D.
• Email: lining@cicams.ac.cn
• Phone: +86 01087788165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.