CD4CAR for CD4+ Leukemia and Lymphoma (NCT03829540)

🧪 Interventions in This Study

• CD4CAR (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. In order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:
2. Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability for the duration of the study.
3. Age 12 years old or older
4. Subjects with any documented CD4+ T cell hematologic malignancies. Male and female subjects with CD4+ T-cell hematologic malignancies with either relapsed or refractory disease (including those patients who have undergone a prior transplant (if allogeneic, subjects are eligible if there are no remaining donor cells) and patients with an inadequate response after 4-6 cycles of standard chemotherapy) are eligible. Response criteria for each disease subset will be evaluated based on Standard of Care Guidelines.
5. Creatinine clearance of \> 60 ml/min (or otherwise non clinically-significant, per study investigator)
6. ALT/AST \< 3 x ULN
7. Bilirubin \< 2 x ULN
8. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion
9. Adequate cardiac function with EF of ≥50%
10. Adequate venous access for apheresis and no other contraindications for leukapheresis

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana
• Riley Hospital for Children — Indianapolis, Indiana
• Albert Einstein Health Network — New York, New York
• Stony Brook Cancer Center — Stony Brook, New York
• The University of Texas MD Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (317) 278-4184

Email: tnhaney@iu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Next, participants will receive conditioning chemotherapy.

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• Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma — Columbus, Ohio
• A Study of Enasidenib in People With T-Cell Lymphoma — Basking Ridge, New Jersey
• A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma — Palo Alto, California

Explore by condition: All T-cell Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.