CD5 CAR-T Cells in Relapsed or Refractory T-cell Malignancies
A Phase 1/2 multi-center study evaluating CD5-targeted CAR T-cell therapy in adults and children with relapsed or refractory CD5-positive T-cell leukemia or lymphoma. CancerFax helps patients and families understand the trial, organize medical records, and coordinate with the trial team in China.
About This Clinical Trial
T-cell malignancies, including T-cell acute lymphoblastic leukemia (T-ALL), T-cell lymphoblastic lymphoma, and aggressive peripheral T-cell lymphomas, are a difficult group of blood cancers. When the disease relapses after chemotherapy or does not respond to standard treatment, prognosis is typically poor and curative options are limited, especially for patients who are not candidates for stem-cell transplantation or have already relapsed after one.
Unlike B-cell cancers, where CAR T-cell therapies targeting CD19 or BCMA have become a major breakthrough, T-cell cancers have historically been much harder to treat with CAR-T. This is because the same proteins that mark cancerous T-cells are also present on healthy T-cells, creating a risk that the CAR-T product attacks itself during manufacturing (fratricide) and that healthy immunity is depleted.
This Phase 1/2 trial (NCT06316856) is evaluating an anti-CD5 CAR T-cell therapy in patients with CD5-positive relapsed or refractory T-cell malignancies. The study uses three different cell sources to suit different clinical situations: autologous (patient's own) cells, cells from a previous stem-cell transplant donor, and cells from a newly matched donor. A Bayesian optimal interval (BOIN12) design is used to identify the optimal biological dose and recommend a Phase 2 dose.
The primary endpoints in Phase 1 are dose-limiting toxicity (DLT) within 28 days and the incidence and severity of adverse events within 30 days after CD5 CAR T-cell infusion. In Phase 2, the primary endpoint is the best overall response (BOR) at 3 months after infusion. The trial is being run by Beijing GoBroad Hospital with several other Chinese cancer centers as collaborating sites.
Whether anti-CD5 CAR T-cell therapy is safe and tolerable in patients with relapsed or refractory CD5-positive T-cell malignancies, what the optimal dose is, and whether it can produce meaningful disease control at 3 months after infusion.
Trial at a Glance
A quick summary of the key facts about this trial. This is for general orientation only and is not a confirmation that any specific patient is eligible.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
The investigational treatment is a CAR T-cell therapy directed at CD5, a protein expressed on most T-cell leukemias and lymphomas.
The trial uses three cell sources to fit different patient situations: the patient's own T-cells (autologous), cells from a previous stem-cell transplant donor, or cells from a newly matched donor. The right cell source is determined by the patient's transplant history, disease burden, and what is achievable for cell manufacturing.
How CD5 CAR-T works (in simple terms)
T-cells are collected from either the patient or a matched donor and then genetically engineered in the lab to recognize CD5, the protein on the surface of T-cell cancer cells. After short-term chemotherapy to make space for the new cells (lymphodepletion), the CD5 CAR T-cells are infused back into the patient. Inside the body, they look for CD5-positive cells and attack them. Because healthy T-cells also carry CD5, careful clinical monitoring is essential during the first weeks after infusion.
T-cells are collected from peripheral blood β either from the patient or from a matched donor, depending on which arm of the trial the patient is enrolled in.
Collected cells are sent to a GMP cell-therapy lab where they are genetically modified to recognize CD5 and then expanded to the target dose.
A short course of chemotherapy is given to lower the patient's existing immune cells so the infused CAR T-cells can expand and work.
The CD5 CAR T-cells are infused intravenously. Dose levels in this trial are 5Γ10β΅, 1Γ10βΆ or 2Γ10βΆ cells/kg (Β±20%), assigned per the trial's BOIN12 dose-finding design.
Patients are monitored in hospital for cytokine release syndrome (CRS), neurologic effects, infections, and blood-count recovery during the first weeks after infusion.
Disease response (best overall response) is assessed at 3 months after infusion. Safety, pharmacokinetics, progression-free and overall survival are followed up to 2 years.
CD5 CAR T-cell therapy is not an approved standard treatment. It is being studied in clinical trials and is offered only to patients who meet the trial's specific criteria.
Who This Trial May Be For
This trial is being studied for patients whose CD5-positive T-cell cancer has come back or has not responded to standard therapy, and who do not currently have curative options through chemotherapy or stem-cell transplant alone. Final eligibility is decided by the trial investigators after reviewing complete medical records.
Patients with CD5-positive T-cell malignancies (such as T-ALL or T-cell lymphoma) that have progressed after standard therapies or are intolerant of standard care, with no currently available curative option.
Tumor must be CD5-positive: more than 80% of cells by flow cytometry (with less than one log difference in mean fluorescence intensity from normal T-cells), or more than 30% positive by immunohistochemistry.
The trial enrolls both children and adults across a wide age range, from 1 year up to 70 years, with appropriate consent procedures for each age group.
Patients should be functioning well enough to undergo cell collection, lymphodepleting chemotherapy, and CAR-T infusion. ECOG 0, 1, or 2 is required, with a life expectancy of at least 60 days.
For the autologous CD5 CAR T-cell arm, peripheral blood tumor burden must be less than 20%, with anti-neoplastic therapy held for more than 2 weeks before cell collection.
All trial sites are in China. International patients must be willing and able to travel for screening, hospitalization, and follow-up. CancerFax can help with case review, logistics, and coordination.
Eligibility Criteria
These eligibility criteria are summarized from the public trial protocol. Meeting some criteria does not mean a patient is eligible. The full protocol contains many more details, and only the trial investigators can confirm whether a specific patient qualifies after detailed review.
check_circleInclusion Criteria β May Be Eligible
- βRelapsed or refractory CD5+ T-cell malignancy that has progressed after all standard therapies or where the patient is intolerant of standard care, with no available curative option (such as stem-cell transplantation or chemotherapy)
- βFor the autologous CD5 CAR-T arm: peripheral blood tumor burden less than 20% and anti-neoplastic treatment held for more than 2 weeks
- βAged 1 to 70 years
- βNo severe allergies
- βECOG performance status 0, 1, or 2
- βLife expectancy of at least 60 days
- βCD5-positive blasts in bone marrow or cerebrospinal fluid and tumor tissue (>80% by flow cytometry with less than one log difference in MFI from normal T-cells, or >30% positive by immunohistochemistry)
- βSigned informed consent (with age-appropriate guardian consent for children)
- βFor the newly matched donor-derived arm: available allogeneic hematopoietic stem cell transplant donor, with willingness to proceed to SCT if complete remission is achieved
cancelExclusion Criteria β May Not Be Eligible
- ΓImpaired consciousness or signs of intracranial hypertension
- ΓSymptomatic congestive heart failure or severe cardiac arrhythmia
- ΓSevere respiratory system failure
- ΓCo-existence of other active malignancies
- ΓDisseminated intravascular coagulation (DIC)
- ΓSerum creatinine and/or BUN β₯ 1.5 times the upper limit of normal
- ΓSepsis or other uncontrolled infection
- ΓUncontrolled diabetes
- ΓSerious mental illness
- ΓActive intracranial lesions on cranial MRI
- ΓPrior organ transplantation, other than stem-cell transplant
- ΓPregnancy
- ΓPositive test for hepatitis, HIV/AIDS, or syphilis
- ΓPatients planned for newly matched donor-derived CD5 CAR-T where post-CAR SCT is not feasible
- ΓInability to collect peripheral blood mononuclear cells (PBMC), or no frozen PBMC available for CAR-T manufacturing
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
Cell-therapy trials need clean, complete documentation before any site review. CancerFax helps patients and families organize the right reports in the right order so the trial team can review the case faster.
How the Trial Process May Work
Cell-therapy trials involve more steps than most cancer trials. From the first case review to follow-up, the path typically includes the following stages.
Medical reports are reviewed by the trial coordination team to check whether the case fits the trial's basic criteria. CancerFax helps organize the records and translate where needed.
The trial team confirms or rules out eligibility based on diagnosis, CD5 status, prior treatments, organ function, and overall fitness.
If preliminarily eligible, the patient travels to the trial hospital in China for screening tests, including imaging, repeat biopsies, lab work, and cardiac/pulmonary assessment.
The trial team explains the protocol, risks, benefits, and alternatives. Patients (and guardians for children) sign informed consent before any trial procedure.
T-cells are collected from the patient or donor, manufactured into CD5 CAR T-cells, and infused after lymphodepleting chemotherapy. Patients are admitted to hospital for the infusion and early monitoring.
Patients are monitored for CRS, ICANS, infections, and blood-count recovery in the early weeks, then followed up to 2 years for response, safety, PFS, and OS.
Potential Benefits
Clinical trials may offer access to therapies that are not yet routinely available. For relapsed or refractory T-cell malignancies, where standard options are limited, trials like this one may provide an important pathway β but they do not guarantee benefit and must be balanced against risks.
CD5 CAR-T is not an approved treatment anywhere in the world for T-cell cancers. Trial participation is currently one of the only ways to access this kind of therapy.
Trial sites are experienced cell-therapy centers with hematology, transplant, ICU, and supportive-care teams working together.
Trial patients are monitored more intensively than in routine care, with structured follow-up visits, scans, and laboratory tests.
Treatment selection is based on CD5 expression on the tumor, helping match the patient to a therapy that targets a confirmed biological feature of the disease.
The protocol allows autologous, prior-transplant-donor, and newly matched donor CAR-T cells, which gives flexibility for patients who may not be candidates for one approach.
Data from this trial will help shape how CD5 CAR-T is used for T-cell cancers in future, potentially benefiting other patients with similar diseases.
A trial may or may not directly benefit the individual patient. Realistic expectations, careful discussion with the treating team, and clear understanding of risks are essential before any decision.
Risks and Side Effects
Every CAR-T trial carries serious potential risks. For CD5 CAR-T in particular, there are also therapy-specific considerations because CD5 is also expressed on normal T-cells.
CRS is an inflammatory response caused by rapid immune activation. Symptoms include high fever, low blood pressure, and difficulty breathing. It can range from mild to severe and is managed with supportive care and medications such as tocilizumab and steroids.
Lymphodepleting chemotherapy and the CAR-T effect itself can cause prolonged drops in white cells, red cells, and platelets, raising the risk of infection, anemia, and bleeding.
CD5 is present on most normal T-cells, not only on the cancer. CD5 CAR-T can deplete healthy T-cells and weaken immune defense, increasing risk of viral, bacterial, and opportunistic infections.
Some patients develop confusion, tremor, speech problems, or seizures after CAR-T infusion. Most cases are reversible with appropriate treatment, but ICANS can occasionally be severe.
As with most cancer therapies, patients can experience fatigue, nausea, fever, mucositis, and reduced appetite during and after treatment.
Because CD5 CAR-T is investigational, long-term effects on immune function and other organ systems are not yet fully known. Long-term follow-up is part of the protocol.
Travel and time burden, no guaranteed benefit, possible trial discontinuation if cells cannot be manufactured at the planned dose, and the need for prolonged hospital monitoring should all be weighed carefully with the family and the treating team.
Trial Location and Hospital Information
The trial is being run as a multi-center study in China, led by Beijing GoBroad Hospital. Active sites include Beijing, Shanghai (Zhaxin Hospital and Liquan Hospital), and Zhanjiang and Guangxi sites, with Chengdu listed as a planned site. All patients, including international patients, need to travel to one of the participating Chinese hospitals for screening, treatment, and follow-up.
International patients typically need a Chinese medical (M) visa, professionally translated medical records, remote case review before travel, accommodation near the hospital, and a clear plan for caregiver travel and follow-up. CancerFax can help with case review, coordination with Beijing GoBroad Hospital and other trial sites, translation, and logistics support.
Costs, Trial Coverage, and Patient Expenses
Costs in CAR-T clinical trials vary significantly by sponsor and site. Some elements may be covered by the trial sponsor, while others β particularly travel, accommodation, and out-of-trial supportive care β are usually the family's responsibility. Final cost confirmation must come from the trial center in writing.
CancerFax helps understand expected cost categories and what is typically covered. Final cost confirmation must come from the trial center in writing before any commitment to travel or treatment. β VERIFY: actual sponsor coverage policy is illustrative and should be confirmed with Beijing GoBroad Hospital.
Standard Treatment vs Clinical Trial
It can be helpful to compare what enrolling in this trial would look like, versus continuing with standard treatment options for relapsed or refractory T-cell malignancies. Each path has trade-offs that should be discussed with the treating oncologist.
How CancerFax Helps Patients Explore This Trial
CancerFax is a specialist cancer patient-navigation and advanced cancer treatment access platform. For complex cell-therapy trials like this CD5 CAR-T study, we help patients and families prepare, communicate with the trial site, and understand what is realistic at each step.
We review medical records β pathology, flow cytometry, IHC, imaging, treatment history β and identify what is missing or unclear before case submission.
We help organize records into a structured summary so the trial team can assess eligibility faster, and flag any gaps that must be addressed first.
We coordinate with Beijing GoBroad Hospital and other participating sites to share medical records and request preliminary review where appropriate.
We help with visa support, travel planning, accommodation, hospital admission documents, and on-the-ground logistics for international patients and caregivers.
We explain how the trial works, what each step looks like, and help compare it with other relevant trials or treatment pathways for T-cell malignancies.
From first case review to post-treatment follow-up, we stay involved as a single point of contact for the patient, family, and trial team.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
These are useful questions for patients and families to discuss with the trial team and their own oncologist before deciding on participation. Informed questions help everyone make a clearer, safer decision.
Frequently Asked Questions
Want to Know Whether This Trial May Be Relevant?
If you or a family member has been diagnosed with relapsed or refractory CD5-positive T-cell leukemia or lymphoma, CancerFax can help review the case, organize medical records, and coordinate with the trial team at Beijing GoBroad Hospital and partner sites.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
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Β© CancerFax Β· Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.